<ichicsr lang="en">
  <ichicsrmessageheader>
    <messagetype>ICSR</messagetype>
    <messageformatversion>2.1</messageformatversion>
    <messageformatrelease>1.0</messageformatrelease>
    <messagenumb>2007-11</messagenumb>
    <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
    <messagereceiveridentifier>Public Use</messagereceiveridentifier>
    <messagedateformat>204</messagedateformat>
    <messagedate>2008040505:58:22</messagedate>
  </ichicsrmessageheader>
  <safetyreport>
    <safetyreportid>5503632-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-SYNTHELABO-A01200711050</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>021287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503633-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200708968</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>600 MG IV BOLUS FOLLOWED BY 3750MG CONTINUOUS INFUSION ON D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503634-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712140</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503635-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706114</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>TOOK 5 MG 1 TAB HS, THEN TOOK 2 MORE DOSES LATER ON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>325/5 MG - 2 TAB EVERY 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 TAB FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 TAB HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503637-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706185</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>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503638-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A04200701448</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>1 GLASS OF STRONG BEER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503639-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200700939</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>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200703170</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061224</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE16006</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>9597</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US04652</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG 1/2 TO 1 TAB DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>87840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERSURE</medicinalproduct>
        <drugdosagetext>QD, PO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02468</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASICOR</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP07803</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060914</drugenddate>
        <drugtreatmentduration>80640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDERON</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>750 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02066</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US04893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15535</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503648-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP13329</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</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>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>235</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061123</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>3.75 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503649-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13433</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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0038</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503650-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02034</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, TID WHEN NECESSARY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>10 MG, Q4H WHEN REQUIRED FOR SEVERE PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
        <drugdosagetext>1 TABLET PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID WHEN REQUIRED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503651-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE16291</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>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>180 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503652-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16385</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL ALVEOLAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</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>20060714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>428</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYSRON</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>MALIGNANT ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FR15780</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>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>50791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>3 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP08764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>2100 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>150 UG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINARON</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>60 ML/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGACIN</medicinalproduct>
        <drugdosagetext>0.9 G/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503655-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AR17911</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASOFORTINA</medicinalproduct>
        <drugauthorizationnumb>6035</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugdosagetext>1 BOX AT ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR07294</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>GASTRIC POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>UP TO 3 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503657-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006PL20048</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061126</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOZEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17939</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>12 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE03159</companynumb>
    <primarysource>
      <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>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHERESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOLOGY ABNORMAL</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>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH RESORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>186 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>ESCHERICHIA BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>48 MILLION UNITS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007ES17333</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LMF237 VS VILDAGLIPTIN VS METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>HYPOGONADISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503661-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GR17866</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17822</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02496</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03586</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>180MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503665-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03159</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugdosagetext>5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>4MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503666-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GR17863</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGOSTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZURCAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIMEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AR17826</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLPER B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE17865</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>15 MG/KG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02031</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03588</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US17851</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>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN REDUCTION OF FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4MG EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <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>20030820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503674-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007KR17480</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503675-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAST APPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BONE PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE16649</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>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 3-4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007GB16416</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>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC VS EVEROLIMUS</medicinalproduct>
        <drugdosagetext>1080 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORGAN TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORGAN TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503678-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB01903</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG MANE, 200MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR03559</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10291</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>50 TO 95 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>1009</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>95MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040319</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>95MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007VE04319</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17887</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03147</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006DE03763</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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUILONUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREVILOR</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US18039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE324103APR07</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>OBSTRUCTIVE CHRONIC BRONCHITIS WITH ACUTE EXACERBATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WYE-G00525907</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071004619</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>TMC114</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugauthorizationnumb>062477</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>1</drugcharacterization>
        <medicinalproduct>MK-0518</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CASTLEMAN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503691-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20061000428</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugauthorizationnumb>062477</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>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071005963</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006262</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRANIDAZOLE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY: EVERY OTHER WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>RECEIVED FOR YEARS</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>RECEIVED FOR YEARS</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071006316</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070901955</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 3 DOSINGS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503696-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503697-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071002986</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503698-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070603686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3-6 MONTHS</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>{ 3 MONTHS</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007128</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugbatchnumb>KCL144</drugbatchnumb>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPROSONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIDIAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007011</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>KAL149</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>KAL149</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804761</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804758</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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 REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804759</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804760</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804754</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804755</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503707-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804756</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804743</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GE-JNJFOC-20070804753</companynumb>
    <primarysource>
      <reportercountry>GEORGIA</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503710-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071005819</companynumb>
    <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>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007142</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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503713-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0709093</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0709093</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503714-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007003</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007006</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0709092;0706104</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0709092;0706104</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006773</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE PATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503720-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20071006706</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>FOR 2 YEARS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071007782</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>25 MG IN THE MORNING AND 100 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070803995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00921207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOADING DOSE, THEN 50 MG Q 12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503724-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00889807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOADING DOSE, THEN 50 MG Q 12H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503725-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00890007</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>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugdosagetext>100 MG LOADING DOSE, THEN 50 MG Q 12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AROUND THE CLOCK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070900825</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>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503727-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071003280</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071003421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugauthorizationnumb>021692</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503730-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-TYCO HEALTHCARE/MALLINCKRODT-T200701275</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugbatchnumb>7010055</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>50 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZILARVIR</medicinalproduct>
        <drugdosagetext>1 TABLET BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRIXIVAN                           /01304201/</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>1 TABLET, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-NOVOPROD-268918</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>22 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503732-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAUSCH-2007BL001986</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>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMIN GLOBULIN RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS ORBITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMAL GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFACETAMIDE SODIUM</medicinalproduct>
        <drugbatchnumb>147371</drugbatchnumb>
        <drugauthorizationnumb>040066</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATTOKINASE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE EXTRACT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GREEN POWER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GREEN TEA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMON OIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00207034527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23945</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>116.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 2.5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPOGONADISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 3.75 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 81 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  37.5/325 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1000 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 145 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .9 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 320 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .45 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>491</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 15 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503749-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0421881-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503752-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711199BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503753-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-200715816GDS</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBX3C1</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugdosagetext>AS USED: 10 MG  UNIT DOSE: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRABOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELITON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 2.5 MG  UNIT DOSE: 2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTONIS</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710756BYL</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>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN OD</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 5 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1.0 MG  UNIT DOSE: 0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUNCHO-TO</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.5 G  UNIT DOSE: 2.5 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 45 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 45 MG  UNIT DOSE: 15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1500 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAKKON-TO</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 3.0 G  UNIT DOSE: 1 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 300 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SOLVAY-00207034655</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19383</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugauthorizationnumb>20184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503770-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13897525</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>27JUN07-2JUL07;12MG,6DAYS.03-JUL-11JUL 24MG/DAY.12JUL-7AUG:30MG, 3WEEK 6DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>50 MG 4 WEEKS 1DAY. 31JUL07-7AUG07;DOSE INCREASED TO 150 MG ON 31-JUL-2007, 1WEEK 1DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN LACTATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HCL</medicinalproduct>
        <drugdosagetext>06-AUG-2007 TO 8AUG. DOSE 2G.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGERS SOLUTION, LACTATED</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTENANCE MEDIUM 5</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503771-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13955042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HIV RNA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugindication>HEPATITIS B VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503772-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13956883</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>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13959929</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DZ-BRISTOL-MYERS SQUIBB COMPANY-13962469</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugauthorizationnumb>20758</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM=300 MG/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1/2 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1/2 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13946264</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARVEA TABS 300 MG</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503776-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13959457</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13959457</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13746854</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>TAKEN 934 MG IV ON 08FEB07-08FEB07 (1 DAY), 28-FEB07-28FEB07 (1 DAY) AND 21MAR07-21MAR07 (1 DAY).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>TAKEN 438 MG IV ON 08FEB07 (1 DAY), 28FEB07 (1 DAY), AND 21MAR07 (1 DAY).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SORAFENIB</medicinalproduct>
        <drugbatchnumb>CT2176/29</drugbatchnumb>
        <drugdosagetext>TAKEN 800 MG ORAL ON 09FEB07-26FEB07  2 WEEKS 4 DAYS, 01MAR07-18MAR07 2 WEEKS 4 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
        <drugdosagetext>1 DOSAGEFORM = 5-10 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANODERMA LUCIDUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY</medicinalproduct>
        <drugdosagetext>1 DOSAAGEFORM = 220-440 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13964002</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 150 MG</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM =1/2 TABLET.DOSE REDUCED FROM 150MG/DAILY TO 75MG/DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELO-ZOK TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>TREATMENT STARTED 16 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13964572</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
        <drugauthorizationnumb>16295</drugauthorizationnumb>
        <drugdosagetext>DRUG INTERRUPTED AND THEN RESTARTED AT A LOWER DOSE AND THEN DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13961917</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>20757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-BRISTOL-MYERS SQUIBB COMPANY-13950217</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>CHYLOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-13960380</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13961321</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugdosagetext>STARTED ON 17APR07,CUMULATIVE DOSE TO 2291 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL INJ 100 MG/16.7 ML</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>WITH A TOTAL CUMULATIVE DOSE OF 34326.8MG (1930MG AT LATEST COURSE).</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13866660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugdosagetext>800MG IN THE FIRST CYCLE.880MG IN THE SECOND CYCLE. 900MG FOR THE REMAINING 4 CYCLES.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugdosagetext>80MG IN THE FIRST;88MG IN THE SECOND AND 90MG FOR THE REMAINING 4 CYCLES.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE144413SEP07</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>016418</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTARIUM</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008406-07</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHARCOAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN AMOUNT GIVEN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JIMSON SEEDS</medicinalproduct>
        <drugdosagetext>PATIENT STATED HE ATE A POT FULL OF JIMSON SEEDS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSOSTIGMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP06932</companynumb>
    <primarysource>
      <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>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
        <drugtreatmentduration>757</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
        <drugtreatmentduration>757</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050224</drugenddate>
        <drugtreatmentduration>494</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP14181</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17890</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17876</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17618</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLINESTERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20539</drugauthorizationnumb>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>A FEW BOTTLES OF BEER/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17858</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17916</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX17678</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17016</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>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>1 TABLET/ TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>3 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13951348</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORBITAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugauthorizationnumb>012041</drugauthorizationnumb>
        <drugdosagetext>TRIAMCINOLONE ACETONIDE WAS GIVEN AS SUBTENON INJECTION.</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>RETINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLISTIMETHATE SODIUM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503818-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13834544</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>21986</drugauthorizationnumb>
        <drugdosagetext>15-MAY-2007 TO 25-MAY-2007 - 140 MG, RESTARTED ON 03 JULY 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714054BWH</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD 001</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 35 MG</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>METASTATIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02090</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>171</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710784BYL</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>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712824BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 325 MG  UNIT DOSE: 325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713485BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER PLUS COLD + COUGH LIQUID</medicinalproduct>
        <drugbatchnumb>237706N</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245807</companynumb>
    <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 OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>2.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOTHALAMO-PITUITARY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00207034527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23945</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>116.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 2.5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPOGONADISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 3.75 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 81 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  37.5/325 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1000 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 145 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .9 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 320 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .45 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>491</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 15 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00877407</companynumb>
    <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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006017</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARCOTIC ANALGESICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANILAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVE VIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICAL OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071005482</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>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR SEMINOMA (PURE)</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</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>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-13950753</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GERM CELL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GERM CELL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GERM CELL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20070905258</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA703</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA703</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070902709</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070902960</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <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>
      <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>
        <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>IMURAN</medicinalproduct>
        <drugdosagetext>25-50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070505511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST RECEIVED 3 VIALS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST RECEIVED 3 VIALS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST RECEIVED 3 VIALS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007966</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>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711906US</companynumb>
    <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>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ALLERGAN-0711842US</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTABEX</medicinalproduct>
        <drugbatchnumb>C1797</drugbatchnumb>
        <drugdosagetext>50 UNITS, SINGLE</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711194BVD</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200616048BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KERATOACANTHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200614268BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DTIC-DOME</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030703</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DTIC-DOME</medicinalproduct>
        <drugauthorizationnumb>017575</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DTIC-DOME</medicinalproduct>
        <drugauthorizationnumb>017575</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MDX - 010 (BMS734016) - (IPILIMUMAB)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MDX - 010 (BMS734016) - (IPILIMUMAB)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MDX - 010 (BMS734016) - (IPILIMUMAB)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710958BNE</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>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13952999</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM= 30000(NO UNITS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13947635</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>1 TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LERCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13965645</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HOLOXAN</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247260</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ELI_LILLY_AND_COMPANY-AT200710006920</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710006785</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709001841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A302400</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>625 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, 2/D</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710007234</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGORADICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ELI_LILLY_AND_COMPANY-NZ200608006728</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200709003117</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOAFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PURDUE-GBR_2007_0003154</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 5 MG</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 5 MG</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 5 MG</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 5 MG</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOCARD</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM ALGINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugdosagetext>1 TO 3 DOSES UNIT, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>2 TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugdosagetext>3 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG 2</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAGNESIUM DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070203101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070401618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503905-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2006-0010798</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503908-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0011030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.407</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOSYNCRATIC DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GILEAD-2007-0013838</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2007-0013942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250125</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOSTATIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>4 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-HYDROXYTRYPTAMINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRATION NOS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (UNK INGREDIENT)</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>5 A?G/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-428833</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>
      <patientweight>66.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503916-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-494043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL FEAR</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>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISPORIN</medicinalproduct>
        <drugadministrationroute>001</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICORT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384554</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>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V LEIDEN MUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN: EVERY DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-21</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ORTHO TRI-CYCLEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503920-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-479474</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>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS OF SMALL BOWEL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-492129</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REPORTED AS PEGASYS 180 MCG.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS RIBAVIRIN 800 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503924-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-428465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>147</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA NUMMULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-500461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>THE PATIENT WAS DISPENSED ACCUTANE 20 MILLIGRAM CAPSULES ON 16JAN2007, 25FEB2007 AND 26MAR2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-207220</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030314</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-526854</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503928-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527777</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>TAKES ON THE FOURTH SUNDAY OF EACH MONTH.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527495</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>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503930-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-511007</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 180 MCG/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 135 MCG/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503931-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-493269</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEREAVEMENT REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503932-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-07P-013-0421821-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503944-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BRACCO-BRO-012301</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL MYELOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13964945</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13965504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>155MG FORM 25-APR-2005 TO NI, 154MG FROM 16-MAY-2005 TO NI.</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503951-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-QUU248554</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503957-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GENENTECH-236762</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOT SPECIFIED)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON (FRANCE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILDIEM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANTHIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOASPIRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503958-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AMGEN-UK231842</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503959-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK245328</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503965-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GENENTECH-248824</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503971-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200705006612</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</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>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710004896</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>99</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOTILDIEM</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>7.5 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503973-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710006065</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>742.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>111 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>211</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>20070302</drugstartdate>
        <drugtreatmentduration>113</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>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MASKIN</medicinalproduct>
        <drugdosagetext>400 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503976-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005012</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710004870</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>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOTILDIEM</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>7.5 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503980-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-249515</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503981-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0710NZL00007</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503982-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA03535</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>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503983-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008001</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>108.86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPLY SLEEP NIGHTTIME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPLY SLEEP NIGHTTIME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503984-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA04312</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>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODINE-131</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL ORALET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528316</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>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528310</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>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528313</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>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528131</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>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT12475</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>30 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR17679</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-527608</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DIVIDED INTO 2 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15170</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>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060904</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060904</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-528080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>ANOREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECABET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11536</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0009</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-486103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS  ORAL FORMULATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17938</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES16854</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, Q8H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-512154</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS: HEPATITIS C, GENOTYPE 1B</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>INDICATION REPORTED AS: HEPATITIS C, GENOTYPE 1B</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>HEPATIC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR</medicinalproduct>
        <drugindication>HEPATIC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugdosagetext>INDICATION REPORTED AS QUICK DECREASE 38%</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugdosagetext>DOSAGE ALSO REPORTED AS: ACTUALLY 2.5 MG DAILY</drugdosagetext>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5503999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-482389</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071006392</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071005369</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>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>REVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AOTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOBION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070905425</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071005483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICOAGULANT THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0702235</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0702235</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071005751</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN SCLEROSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0701670</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugauthorizationnumb>017821</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATICAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006117</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706112</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006184</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706111</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504007-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0540515</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0540515</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504008-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006994</companynumb>
    <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 ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200703002174</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
        <drugdosagetext>0.3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
        <drugdosagetext>0.1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>3600</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 3A</medicinalproduct>
        <drugdosagetext>1500 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON                                /CAN/</medicinalproduct>
        <drugdosagetext>16 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070303</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugdosagetext>200 UNK, UNK</drugdosagetext>
        <drugadministrationroute>039</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN                               /SCH/</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070303</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004926</companynumb>
    <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>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL NERVE STIMULATOR IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A355346</drugbatchnumb>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710005546</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR200710004851</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>5.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0710NZL00008</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05997</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>013400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESYLATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN HUMAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504018-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEARNING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>EXTRA, LONG TERM</drugdosagetext>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>10.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED INFANTS TYLENOL PLUS COLD + COUGH CHERRY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED INFANTS TYLENOL PLUS COLD + COUGH CHERRY</medicinalproduct>
        <drugdosagetext>^1/2 SYRINGE^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0710POL00026</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0710USA07075</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>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA04693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLINZA</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLINZA</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-521576</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>TRADE NAME UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504024-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX14728</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/25MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-527911</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-499416</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-527334</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1 DOSE QD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
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        <drugenddate>20070704</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE INCREASED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAMUDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROSULF</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 2 DOSES PER DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15092</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>2715</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID STIMULATING HORMONE-PRODUCING PITUITARY TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504030-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17338</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 FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL A-D</medicinalproduct>
        <drugauthorizationnumb>020310</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL A-D</medicinalproduct>
        <drugauthorizationnumb>020310</drugauthorizationnumb>
        <drugdosagetext>ONE SHAMPOO</drugdosagetext>
        <drugindication>DANDRUFF</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBERIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006569</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MINIMAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugdosagetext>FOR 3 OR 4 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/DEXTROMETHORPHAN/PSEUDOEPHEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOBENZAMIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYCOSAMINE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SOLVAY-00307034335</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2.5 MILLILITRE(S) AS A SINGLE SHOT SPINAL ANAESTHETIC TECHNIQUE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504044-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13950498</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPOTEN TABS 12.5 MG</medicinalproduct>
        <drugdosagetext>20 TABLETS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17832</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL BILE ACIDS INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUGANNING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO FALK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORYZANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13965165</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13965538</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>BEGAN STUDY DRUG ON AN UNKNOWN DATE,INTERRUPTED AND RESTARTED ON 10-JUL-2006</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>BEGAN STUDY DRUG ON AN UNKNOWN DATE,INTERRUPTED AND RESTARTED ON 10-JUL-2006</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT17439</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13963046</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR17679</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AVENTIS-200719352GDDC</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugdosagetext>DOSE QUANTITY: 1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXIN                           /00697201/</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0570206A</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504066-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0686295A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690453A</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>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690698A</companynumb>
    <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>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690897A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690950A</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7G23</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504071-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485560A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ 2MG LOZENGE</medicinalproduct>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>2MG TWELVE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE INADEQUATELY CONTROLLED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE584912JUN07</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugauthorizationnumb>18553</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>227</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>311</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061221</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719255GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERTUSSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>PERTUSSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712881JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUICK ACTING INSULIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: BEFORE MEALS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719957GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREX                               /00024401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071005346</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXACIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071001702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENECOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504087-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504088-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100055</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504089-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA_2007_0029868</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5504090-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
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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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504091-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504092-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005814</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugbatchnumb>A328615</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504093-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504094-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A343226</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709000248</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>50.794</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005717</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugbatchnumb>A327071</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504098-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504099-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709005334</companynumb>
    <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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A264054</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRISDOL</medicinalproduct>
        <drugdosagetext>50000 IU, WEEKLY (1/W)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504100-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200611004281</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF6D18E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF6F52A</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A263476</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMPRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAMOL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504101-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200704005168</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</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>20051114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
        <drugtreatmentduration>418</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL /CAN/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>1.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTOFORTE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTOFORTE</medicinalproduct>
        <drugdosagetext>50000 IU, 2/W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00831701/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504102-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708005179</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A283355</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504103-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029755</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504104-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006490</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINOPLASTY</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>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504105-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071007798</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504106-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900592</companynumb>
    <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ESGIC-PLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDURAL</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504107-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071005973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504108-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070903530</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20071007191</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504114-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071001406</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NERVE DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504115-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20071006228</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504116-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070902988</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504117-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071002532</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>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYSTERICAL PSYCHOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504118-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENENTECH-250177</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504124-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-KINGPHARMUSA00001-K200701399</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY NAIL REFILL TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>.3 MG, SINGLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504131-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245823</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 MG, 1/MONTH</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 A?G, UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504132-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0662831A</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>110.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0670189A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>7ZP7324</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680222A</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>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682776A</companynumb>
    <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>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0685938A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugbatchnumb>R293054</drugbatchnumb>
        <drugauthorizationnumb>020692</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504137-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689813A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689840A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504139-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690120A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504140-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690303A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690326A</companynumb>
    <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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLD MEDICINE (UNSPECIFIED)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504142-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690333A</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>5TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504144-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690334A</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>0094</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504145-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690525A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>1MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504146-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690534A</companynumb>
    <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>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504147-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690545A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504148-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690547A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504149-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690556A</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>0219</drugbatchnumb>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504151-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690568A</companynumb>
    <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>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504152-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690575A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504153-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690586A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>7ZP0862B</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504154-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690769A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504155-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690786A</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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSKI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690790A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504157-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690797A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504158-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690803A</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504159-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANOMALOUS PULMONARY VENOUS CONNECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504160-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690843A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504161-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690844A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504162-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690845A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690846A</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>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690848A</companynumb>
    <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 ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690849A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690850A</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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690858A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690865A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690866A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504170-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691056A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691102A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691114A</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>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>019389</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961031</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOYL PEROXIDE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504173-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691116A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MGD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504174-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0456784B</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPHONYLUREA</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0462234A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504176-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0466987A</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>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060915</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETENSIEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504177-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0472905A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugauthorizationnumb>50578</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NETILMICIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010831</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504178-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0475856A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1650MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504179-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0482726B</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL AORTIC ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>6TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE B6</medicinalproduct>
        <drugdosagetext>6TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON B9</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504181-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0484998A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504182-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485158A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504183-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485300A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCOAGULABLE STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTURE SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</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>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504184-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485301A</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>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504185-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485806A</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>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>24MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDARABINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486341A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATIC HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
        <drugtreatmentduration>218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486577A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugbatchnumb>3717 (M01001)</drugbatchnumb>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugdosagetext>2SPR AS REQUIRED</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487370A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488034A</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>63.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>FACET JOINT SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACET JOINT SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504190-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488741A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21548</drugauthorizationnumb>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACINE</medicinalproduct>
        <drugdosagetext>300MG EIGHT TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBRAL TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488850A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489254A</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>
      <patientweight>62.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504193-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489256A</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>60.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</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>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC</medicinalproduct>
        <drugdosagetext>1000ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489550A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490425A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>BF6363</drugbatchnumb>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504196-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490666A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504197-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490825A</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECOTIDE 250 MCG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19389</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTODISK</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>4PUFF PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOCODION</medicinalproduct>
        <drugdosagetext>4UNIT PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504198-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491377A</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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504199-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491768A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</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>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>U PAN</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>15MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491771A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492058A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492505A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492739A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>1G AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN</medicinalproduct>
        <drugindication>HYPOPHYSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493268A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPUGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493293A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493298A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELARABINE</medicinalproduct>
        <drugauthorizationnumb>21877</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504207-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493420A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>320MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>3200MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>1920MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>1480MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRITS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVATED CARBON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID REPLACEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493510A</companynumb>
    <primarysource>
      <reportercountry>ZIMBABWE</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>20857</drugauthorizationnumb>
        <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>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493586A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUPRET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493587A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1850MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054513A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELONTRIL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>150MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYLAMINE</medicinalproduct>
        <drugdosagetext>25MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMIPRAMINE MESILATE</medicinalproduct>
        <drugdosagetext>30ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugdosagetext>7.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLEEPING MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504213-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707004086</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504214-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004043</companynumb>
    <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 STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A324158</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504215-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709000204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504216-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504217-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709001689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</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>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504218-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006000</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504219-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504220-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341152</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341152</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341152</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>100 IU, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugdosagetext>750 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/APAP</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>5000 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYADEC</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710004714</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504222-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A324158</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504223-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003479</companynumb>
    <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>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311536</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00519207</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504227-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE288211SEP07</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYCOBACTERIUM ABSCESSUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYCOBACTERIUM ABSCESSUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34.93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>PFM088</drugbatchnumb>
        <drugauthorizationnumb>020601</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>PFM088</drugbatchnumb>
        <drugauthorizationnumb>020601</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>PFM088</drugbatchnumb>
        <drugauthorizationnumb>020601</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>PFM088</drugbatchnumb>
        <drugauthorizationnumb>020601</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504235-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029902</companynumb>
    <primarysource></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>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029876</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-ANXIETY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GILEAD-2007-0013932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO TRIMOXAZOLE</medicinalproduct>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE</medicinalproduct>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-07P-013-0421752-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-07P-013-0375607-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504243-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504244-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CR-GILEAD-2007-0011707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
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  <safetyreport>
    <safetyreportid>5504245-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
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    <companynumb>MX-GILEAD-2007-0013795</companynumb>
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      <reportercountry>MEXICO</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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        <drugstartdate>20070701</drugstartdate>
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      <drug>
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        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
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        <drugenddate>20070616</drugenddate>
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  <safetyreport>
    <safetyreportid>5504248-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
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    <companynumb>US-GILEAD-2007-0013908</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5504249-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
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    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
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    <companynumb>US-GILEAD-2007-0013377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL MULTIPLEX ARTHROGRYPOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
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        <drugstartdate>20060816</drugstartdate>
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        <drugenddate>20070509</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
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        <drugenddate>20070509</drugenddate>
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    <safetyreportid>5504250-2</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedate>20071101</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
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        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOSTATIN</medicinalproduct>
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        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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    <safetyreportid>5504251-4</safetyreportid>
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    <receivedate>20071101</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
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        <drugstartdate>20070820</drugstartdate>
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        <drugenddate>20071013</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
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        <drugenddate>20071013</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugenddate>20071013</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
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        <drugindication>HYPOKALAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
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        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
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        <drugenddate>20071013</drugenddate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
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        <drugindication>DEPRESSION</drugindication>
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        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
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    <safetyreportid>5504252-6</safetyreportid>
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    <receivedate>20071101</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20070312</drugstartdate>
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      <drug>
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        <medicinalproduct>EFAVIRENZ</medicinalproduct>
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        <medicinalproduct>EPZICOM</medicinalproduct>
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      <reportercountry>JAPAN</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
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        <medicinalproduct>URSODIOL</medicinalproduct>
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      <reportercountry>FRANCE</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
        <drugindication>HEPATITIS B VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13955372</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugbatchnumb>7H28352</drugbatchnumb>
        <drugdosagetext>ANOTHER BATCH NUMBER -  7F31306</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATADAY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-H00767907</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR VERTEBRAL FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROSULF</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504259-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00811207</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-CAN_2007_0000391</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ALLERGAN-0711949US</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOPTIC</medicinalproduct>
        <drugauthorizationnumb>062452</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504265-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-CAN_2007_0000393</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504266-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713438FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDEX                             /00340101/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                           /00002703/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200719936GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-250659</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>VASCULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504272-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0027508</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-G00503407</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>25 MG Q WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504279-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10855</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN BASICS B 600MG FILMTABLETTEN</medicinalproduct>
        <drugauthorizationnumb>76605</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10854</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE TABLETS BP 40MG</medicinalproduct>
        <drugauthorizationnumb>78010</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
        <drugdosagetext>7000 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-07945</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>76421</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504282-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-07757</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>065016</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>5 MG, QID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10841</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILK-ALKALI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS BP 400MG</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>5.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10851</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugbatchnumb>0515</drugbatchnumb>
        <drugauthorizationnumb>076165</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504285-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16997</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10857</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLOPPY IRIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504289-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10862</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN 500 MG FILM-COATED TABLETS</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE 10MG TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL CAPSULES 500MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE 150 MG TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504290-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10863</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugauthorizationnumb>78010</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>200 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>10 ML, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL TABLETS BP 2MG</medicinalproduct>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504292-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-10904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>NEUROBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504293-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028377</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ABBOTT-07P-008-0420272-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711907US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C1981</drugbatchnumb>
        <drugdosagetext>30 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029908</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-027709</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>63.492</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-038075</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>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA6021B</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN                                /CAN/</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFUR MAC</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033366</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>1512</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>.25 MG, BED T.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1000 MG, BED T./AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>250 MG, IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, IN THE MORNING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-029539</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>3081</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHWYE390928SEP07</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>303</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-WYE-H00877707</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE AMOUNT 22.5 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT 5.0 G</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE731421AUG07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2004-041426</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-022241</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>645450</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>UNK, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-022242</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>UNK, 1 DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-013623</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>63037A</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>40 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504319-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040210</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>BLADDER SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9733AA</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018842</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5393A</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA7328A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG/D, FOR 1 WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0356945-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-040641</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040261</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039784</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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-0710127US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089309</companynumb>
    <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>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAROTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007088522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007089009</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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:30MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>DAILY DOSE:300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504335-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007085653</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA RENAL CRISIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RIGHT VENTRICULAR FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>DAILY DOSE:60MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0421824-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006014180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0421692-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL PMO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007073535</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090238</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044285</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007082542</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENILE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugauthorizationnumb>021212</drugauthorizationnumb>
        <drugdosagetext>TEXT:2.5MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2006085502</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011757</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>HERNIA PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1ML</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044386</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007013008</companynumb>
    <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044550</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007029458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007002869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INHALED HUMAN INSULIN</medicinalproduct>
        <drugauthorizationnumb>21868</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INHALED HUMAN INSULIN</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089356</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL TENSION GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504359-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069604</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007061775</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:350MG</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:3200MG</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIRDALUD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007068342</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007061772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.454</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007059051</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007058903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>TOBACCO ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART/PROTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089390</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>TEXT:TID  TDD:60 MG</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044765</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007017742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT EXHAUSTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGLECT OF PERSONAL APPEARANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>TEXT:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504381-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007077496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504382-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089466</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>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007076533</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069589</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2007083926</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO200710006611</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>1 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>2 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>3 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>5 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200705006863</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>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504389-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY SATIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A303749</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </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>DIURETICS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710006524</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 IU, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710000672</companynumb>
    <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>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504394-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006432</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ENDOCRINE ADENOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A271927</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A324160</drugbatchnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.15 UG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504395-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN T3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504396-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007564</companynumb>
    <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>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugbatchnumb>A322537</drugbatchnumb>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugbatchnumb>A322537</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>2000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707006815</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN /USA/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A302400</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 U, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10 U, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504399-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>147.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708004797</companynumb>
    <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</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>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504401-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002298</companynumb>
    <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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ELI_LILLY_AND_COMPANY-IN200710004765</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 UNITS , THRICE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>10 U, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>8 U, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>12 U, FASTING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>10 U, PRE LUNCH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>12 U, PRE DINNER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>16 U, FASTING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>16 U, PRE LUNCH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>16 U, PRE DINNER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 U, FASTING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 U, PRE LUNCH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 U, PRE DINNER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 U, FASTING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 U, PRE LUNCH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 U, PRE DINNER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>J73107</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 U, FASTING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN                               /SCH/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708002523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN LIGHT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200705005599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</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>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>35 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>37.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006377</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A361748</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY SATIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A334512</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006273</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007080473</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPIMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STERCULIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007077612</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG-FREQ:EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:3GRAM-FREQ:EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007077559</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LICHENIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugindication>MOUTH ULCERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALOSPORINS AND RELATED SUBSTANCES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-LACTAM ANTIBACTERIALS, PENICILLINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOGLYCOSIDE ANTIBACTERIALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-PFIZER INC-2007089473</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504412-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089341</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>156.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A334522</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 4/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 D/F, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504416-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ELI_LILLY_AND_COMPANY-AR200709002834</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504417-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007672</companynumb>
    <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>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504418-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2005142159</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL XR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUFTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504419-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421811-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504420-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421504-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</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>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422057-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421810-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-07P-143-0376235-00</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>400/100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>HEAD INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>JOINT INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-07P-229-0421884-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421812-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0360008-00</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>CONGENITAL MULTIPLEX ARTHROGRYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</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>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0421970-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITIGLINIDE CALCIUM HYDRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088396</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BORDERLINE PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENOXYLATE W/ATROPINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-PFIZER INC-2007086416</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANOR</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089374</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.545</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089276</companynumb>
    <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>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504446-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089171</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>CYANOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-PFIZER INC-2007089014</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0421568-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421763-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ABBOTT-07P-055-0422231-00</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOGRAPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504454-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SV-ABBOTT-07P-050-0420833-00</companynumb>
    <primarysource>
      <reportercountry>EL SALVADOR</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </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>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0422336-00</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOMUCASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007090899</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>TEXT:1 SINGLE DOSE</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>EAR PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0304928-00</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MG IN THE MORNING AND 400 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR VIII, RECOMBINANT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709003846</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>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006751</companynumb>
    <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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC BULLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A306560</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A351169</drugbatchnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090613</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089780</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PSYCHOMOTOR SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504466-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089676</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504467-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089773</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>HYPNAGOGIC HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089571</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-PFIZER INC-2007089610</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>TEXT:1.5G</drugdosagetext>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089602</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0420963-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MIGRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIAC ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGISTRAL FORMULA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0357741-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0377331-00</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0012139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2007-0013987</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>AMBRISENTAN</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12G084AB</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421813-00</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504505-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUCOL/TISSEEL KIT STIM4</medicinalproduct>
        <drugbatchnumb>VNT3A052</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RADICAL MASTECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706196</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>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-07P-229-0421887-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0422234-00</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OPPORTUNISTIC INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA00037</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0710GBR00122</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugauthorizationnumb>008506</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADDISON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504540-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DZ-MERCK-0710USA05988</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504541-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0503USA02828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504542-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0710GBR00105</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>20685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504543-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA04695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-MERCK-0710PHL00014</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05658</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504547-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA02996</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070410</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504548-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0702USA04763</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALASSAEMIA BETA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GILEAD-2007-0013913</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013931</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT17439</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROXANE LABORATORIES, INC-2007-DE-06391GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-DE-06325GD</companynumb>
    <primarysource></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>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROXANE LABORATORIES, INC-2007-BP-23351RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>40032</drugauthorizationnumb>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>040032</drugauthorizationnumb>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA RECURRENT</drugindication>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCICLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROXANE LABORATORIES, INC-2007-BP-23472RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>017812</drugauthorizationnumb>
        <drugindication>HYPOMANIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>070433</drugauthorizationnumb>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (NEEDS NO REFRIGERATION)</medicinalproduct>
        <drugindication>NEPHROGENIC DIABETES INSIPIDUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROXANE LABORATORIES, INC-2007-BP-23471RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYMUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>040054</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOXACILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-STEROIDAL ANTI-INFLAMMATORY DRUGS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23634RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>84612</drugauthorizationnumb>
        <drugdosagetext>40 MG, THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504591-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROXANE LABORATORIES, INC-2007-BP-23475RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ROXANE LABORATORIES, INC-2007-BP-23355RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NONSTERIODAL ANTIINFLAMMATORY DRUGS</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504593-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23473RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>077795</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 0.5MG TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROXANE LABORATORIES, INC-2007-BP-23323RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL DIAPHRAGM DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077262</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROGRAFIN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>SCAN WITH CONTRAST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugindication>SCAN WITH CONTRAST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504595-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROXANE LABORATORIES, INC-2007-BP-23370RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077043</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076270</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOACTIVE IODINE TREATMENT</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGLE CLOSURE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>ANGLE CLOSURE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRACLONIDINE</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>ANGLE CLOSURE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL HCL</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>ANGLE CLOSURE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>ANGLE CLOSURE GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504596-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROXANE LABORATORIES, INC-2007-BP-23474RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>65178</drugauthorizationnumb>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504604-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-04516PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18617BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665022A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504607-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21719BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504608-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23252NB</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>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugauthorizationnumb>012836</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17485BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504610-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-11574NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504611-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22588BP</companynumb>
    <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504612-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23317RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISCERAL LEISHMANIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>76844</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR-BOOSTED FOSAMPRENAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXPERIMENTAL INTEGRASE INHIBITOR (L-870812) OR PLACEBO</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HCL</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugindication>PNEUMOCYSTIS JIROVECI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VISCERAL LEISHMANIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugindication>VISCERAL LEISHMANIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILTEFOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VISCERAL LEISHMANIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504613-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23341BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504614-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22619BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504615-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-07074BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504616-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23496BP</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504617-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22610BP</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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE NEBULIZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504618-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22600BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504619-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22598BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23438BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>OCULAR HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504621-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23433BP</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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504622-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23556BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504623-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22733BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504624-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21844BP</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>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504625-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22375BP</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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</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>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504626-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21718BP</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>CARDIZEM LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504627-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21986NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504628-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23513BP</companynumb>
    <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>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504629-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22801BP</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504630-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22627BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504631-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22951PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705255B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705255B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705255B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22626BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504633-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-09520NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504634-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23495BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504635-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23565BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504636-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22579BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504637-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22578BP</companynumb>
    <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 INADEQUATELY CONTROLLED</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>20071009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504638-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22553BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22573BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504640-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22558BP</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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504641-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23558BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504642-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23562BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23509BP</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504644-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22557BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504645-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22809BP</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703709B,7C3201</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504646-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23088BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504647-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23093BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20087BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504649-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22994BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23005BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23007BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23517BP</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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504653-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22435BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504654-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22724BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504655-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22844BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504656-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22602BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504657-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22890BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504658-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23358BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504659-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22960BP</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504660-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20348NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17832</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL BILE ACIDS INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUGANNING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO FALK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORYZANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504728-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013982</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504729-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504746-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-041171</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
        <drugdosagetext>800 MG, 1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEHEXAL</medicinalproduct>
        <drugdosagetext>300 MG, 1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>75 MG, 1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504747-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTMIN/CHLORPROMAZINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504748-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504749-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ASTRAZENECA-2007SE05710</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>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504750-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06551</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28889</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAMBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugdosagetext>DIVIDED DOSES:1-3 TIMES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDIAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDIAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENICA-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504751-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW24973</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504752-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE03268</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASPORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504753-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25028</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504754-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504755-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ASTRAZENECA-2007SE05669</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CURANTYL</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILDRONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504756-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP05306</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070116</drugenddate>
        <drugtreatmentduration>469</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERY THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWNDRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504757-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP06677</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504758-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24861</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504759-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06619</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504760-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25174</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>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504761-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06703</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>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE HYDROCHLORIDE PRESERVATIVE FREE</medicinalproduct>
        <drugauthorizationnumb>071202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504762-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25032</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504763-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE03268</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASPORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504833-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071007190</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>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>2 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006746</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL XR</medicinalproduct>
        <drugauthorizationnumb>021615</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504835-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007546</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAZADYNE ER</medicinalproduct>
        <drugauthorizationnumb>021615</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOE VERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17070</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>120 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>60 MG/D</drugdosagetext>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16936</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALBUMIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR16708</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>1 DF, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02495</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</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>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504840-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16006</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>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</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>20060825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEROSPIRONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>8 MG/DAY</drugdosagetext>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504842-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16007</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>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060705</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060825</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060922</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 50/50</medicinalproduct>
        <drugdosagetext>30 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
        <drugtreatmentduration>83520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504843-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007PT18009</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>3 TO 4 G/D</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504844-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02480</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE CONTRACTURE</drugindication>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugindication>MUSCLE CONTRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504845-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14101</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>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN XR</medicinalproduct>
        <drugauthorizationnumb>021802</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02924</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>
      <patientweight>30</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX17872</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504849-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900758</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CENTRAL LINE INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMACOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504850-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070805467</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROGRAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504851-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18056</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504853-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US17979</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>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RECONSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL NERVE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULVESTRANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504854-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR17866</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>160 / 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALVUS</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18015</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02399</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>1 INFUSION/MONTH</drugdosagetext>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504857-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CA16418</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1080 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504860-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18063</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCADRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504861-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US10472</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>78.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI 571 VS IFN-ALPHA + CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>2377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504862-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17896</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AU17685</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00514507</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL CONVULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG IN THE MORNING AND 75 MG AT NOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504865-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE956331AUG07</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>020377</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/ML FOR 5 ML/MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>020377</drugauthorizationnumb>
        <drugdosagetext>3 MG/ML FOR 16 ML/H</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>020377</drugauthorizationnumb>
        <drugdosagetext>3.0 MG/ML FOR 8 ML/H</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRILA</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504866-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00523507</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE NOT STATED, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugdosagetext>DOSE NOT STATED, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>DOSE NOT STATED, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504867-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060800455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHIC HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SCHISTOCYTES PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504868-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071000168</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504869-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIPIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504870-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071001955</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL DECANOATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT17824</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SANDOZ</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>56160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>2122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060504728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</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>0702240</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0702240</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007VE17679</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504874-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18179</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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 EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADILIT</medicinalproduct>
        <drugadministrationroute>063</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugauthorizationnumb>018245</drugauthorizationnumb>
        <drugadministrationroute>063</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17900</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504880-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504889-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20071005770</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>ALCOHOLIC PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504890-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20071006175</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504891-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071006001</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504895-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071001798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</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>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504898-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H00933807</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>3.25 G (OVERDOSE AMOUNT)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>3.2 G (OVERDOSE AMOUNT)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H00878507</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>3 G (OVERDOSE AMOUNT)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H00933907</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504905-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-JNJFOC-20071007301</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <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>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-ASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070802948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504907-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GR14009</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTATHRIN - SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504908-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR07019</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC PREPARATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504909-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP00771</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>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061220</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070107</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>50400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>NEUROTOXICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELTOUCH</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS REISHIPPU ASTRA</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSISALZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAZUFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN SOL. 3B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECICARBON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504910-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14099</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>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504911-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18057</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>INCISIONAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHONAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504912-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AT17973</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IL17633</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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDACTEROL VS FORMOTEROL VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>12 UG, BID</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR17868</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160 / 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAMIFIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18115</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>12 / 400 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18163</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AR18091</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>ONCE A YEAR</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504921-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17914</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>160 VALS - 12.5 HCT MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>UNK, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSSOPAN</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUSPATALIN</medicinalproduct>
        <drugdosagetext>2 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLCADIL</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugindication>MENIERE'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504922-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17915</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugbatchnumb>Z0032</drugbatchnumb>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>120 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPLEX B FORTE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINOPRIL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504923-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02476</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>021284</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FR15780</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>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>50791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>3 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG, ONCE/SINGLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-TYCO HEALTHCARE/MALLINCKRODT-T200701271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugauthorizationnumb>18163</drugauthorizationnumb>
        <drugdosagetext>2 QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOLITH</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504935-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006008</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504936-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071001189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>APPROX 22 INFUSIONS RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>FOR GREATER THAN 10 YEARS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugbatchnumb>M200E</drugbatchnumb>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugdosagetext>18 ML (8 ML LEFT ARM, 10 ML RIGHT ARM), SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-266010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugbatchnumb>SZF0334</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>SZF0033</drugbatchnumb>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTIZONE                          /00028601/</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-268724</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
        <drugdosagetext>4.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>55 U, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRYOPRECIPITATES</medicinalproduct>
        <drugdosagetext>16 U, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>4 U, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugdosagetext>24 U, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-267713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIMB INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504953-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-268881</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>7.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504954-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-268188</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-268779</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACTH-PRODUCING PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
        <drugtreatmentduration>1281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE                        /00068001/</medicinalproduct>
        <drugdosagetext>50 UG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504956-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-268776</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-H00830107</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICK SINUS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200719963GDDC</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>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020602</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-ZOPICLONE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMILOR</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXERAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060127</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D             /00944201/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE CONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713455FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
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        <drugstartdate>20070920</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713460FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN                            /00955301/</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200709000784</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>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLLAGEN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>900 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>160 UG, 4/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLATE</medicinalproduct>
        <drugdosagetext>45 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugtreatmentduration>428</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719906GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL                           /00582602/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719203GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</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>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIZIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFORT</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIDRONATE DISODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC                              /00661201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENIC SUBSTANCE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504968-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-259485</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>34</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>18-32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADEN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
        <drugtreatmentduration>1999</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLORIAMIN</medicinalproduct>
        <drugdosagetext>.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
        <drugtreatmentduration>1999</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
        <drugtreatmentduration>1999</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
        <drugtreatmentduration>1546</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050927</drugenddate>
        <drugtreatmentduration>775</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710790BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504970-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713234BCC</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>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>243067C</drugbatchnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 81 MG  UNIT DOSE: 81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 0.5 MG  UNIT DOSE: 0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-265737</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>NA</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>42 IU, QD</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713464BCC</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>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 325 MG  UNIT DOSE: 325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 81 MG  UNIT DOSE: 81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5504974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710007115</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>PLEURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>930 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>140 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN ACETATE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>50 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>330 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugdosagetext>1 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATLEP</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070429</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>12 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-07P-009-0419551-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00811207</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422359-00</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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OYSTER SHELL CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422227-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0420271-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.204</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13960158</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>THYMOMA MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13965561</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>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>ALSO TAKEN ON 05-MAR-2007 TO 09-APR-2007</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN ZYDIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEROL 2.6%</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13965546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713557BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR HOLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE 600 PLUS VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713527BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER COLD + COUGH LIQUID</medicinalproduct>
        <drugbatchnumb>248407F</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALLS EUCALYPTUS COUGH DROP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13960513</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>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13966106</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BRISTOL-MYERS SQUIBB COMPANY-13934161</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-515244</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>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-527074</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-527063</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>OTHER INDICATION REPORTED AS LIVER CIRRHOSIS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>OTHER INDICATION REPORTED AS LIVER CIRRHOSIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-514934</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-489908</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>070367</drugauthorizationnumb>
        <drugdosagetext>MAINTENANCE PHASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>070367</drugauthorizationnumb>
        <drugdosagetext>INDUCTION PHASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>070367</drugauthorizationnumb>
        <drugdosagetext>MAINTENANCE PHASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-527916</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTION</medicinalproduct>
        <drugdosagetext>CHEAPER BRAND.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN 1/35-28</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-393478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-479447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR II 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>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>LYMPHOID TISSUE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19911024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLISTEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-519992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE FULMINANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527765</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070506403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071006041</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071003696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060906592</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070904993</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>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTAZOLIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20071006355</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCRINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007078</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>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071007167</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200711109BNE</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200510515BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13960109</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>COLITIS ISCHAEMIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713862BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527386</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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>DOSE: PATIENT TOOK 1.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710795BYL</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW01227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>875</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN W/ MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25283</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-ASTRAZENECA-2007AP06802</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070116</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25047</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL NERVE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUMINATE 5%</medicinalproduct>
        <drugbatchnumb>LA07B089AA</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRODUCT TRANSFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06504</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28873</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>3736</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>2213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>2116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
        <drugtreatmentduration>1105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2005PK00179</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>684</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050126</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANGEROL</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACRINORM</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUITEARS</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071005957</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071006415</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006451</companynumb>
    <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 REHABILITATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20070306193</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>EVERY 6TH-7TH WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100121</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>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13964960</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AVENTIS-200719871GDDC</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-AVENTIS-200719862GDDC</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugindication>COLONIC ATONY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugindication>OVERGROWTH BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713450FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET                            /00731801/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
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        <drugenddate>20070124</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
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        <drugenddate>20070124</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 AND B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC                           /00163401/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
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        <drugenddate>20070124</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE K1</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13965603</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODITEN TABS</medicinalproduct>
        <drugauthorizationnumb>11751</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSIONAL DISORDER, PERSECUTORY TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13965157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL TRACKING TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugauthorizationnumb>021064</drugauthorizationnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>STRESS ECHOCARDIOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13966098</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugdosagetext>CYCLE 1: 06-SEP-2007, CYCLE 2: 27-SEP-2007.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>CYCLE 1: 06-SEP-2007, CYCLE 2: 27-SEP-2007.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>CYCLE 1: 06-SEP-2007, CYCLE: 27-SEP-2007.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13947874</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOMONOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071005947</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505118-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070605217</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHITE PETROLATUM</medicinalproduct>
        <drugdosagetext>DATE OF ADMINISTRATION: ^BEFORE OCT-2006^; DAILY DOSE: ^ADEQUATE DOSE^</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-248846</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007060400</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-247562</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIFERMIN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070225</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>280 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICNU</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>890 MBQ, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMATOPOETIC PROGENITOR CELLS HUMAN</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>100 IU/KG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>1 VIAL, UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-246428</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.3 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US249548</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WASSER V GRAN.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>25 MG, FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>100 MG, FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505134-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00815907</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CLEAR CELL CARCINOMA OF THE KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US244561</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>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>2006P2161</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>2006P2161</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEMIDON</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS SKIN TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>^10^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>^30^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>^10^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505136-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK233235</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505142-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF TESTIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P065267</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P065267</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505148-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249375</companynumb>
    <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>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249299</companynumb>
    <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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P103316</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086301</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249481</companynumb>
    <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL243003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEIBOMIANITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SALINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA HA VACCINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL245978</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-ASTRAZENECA-2007AP06465</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP06701</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505160-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB01228</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>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTETRACYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW01701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14489</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>85.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>600 TO 900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1643</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>25 MG TO 50 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
        <drugtreatmentduration>1939</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP05925</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02182</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE + FORMOTEROL</medicinalproduct>
        <drugauthorizationnumb>21929</drugauthorizationnumb>
        <drugdosagetext>TAKEN BY MOTHER FOR ASTHMA</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>TAKEN BY MOTHER FOR DEPRESSION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>TAKEN BY MOTHER FOR ASTHMA</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06743</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW02168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3845</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>250 MG/5 ML SYRUP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG/5 ML LIQUID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>60 GM OF OINTMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 AM AND 750 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHEN</medicinalproduct>
        <drugdosagetext>12.5 MG/5 ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070218</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>10 MG - 20 MG Q AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>20 MG AM + NOON, 10 MG Q 4 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000112</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG - 0.2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG BID AND 4 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06770</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>PERIPARTUM CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOMETRINE MALEATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06604</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20455</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070513</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505169-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-US250512</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>ALBUMIN GLOBULIN RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505171-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US236578</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN THEN DECREASED TO 25 MG ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL225614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P099842,P084105</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK242476</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13718</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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, Q12MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02352</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>21817</drugauthorizationnumb>
        <drugdosagetext>5 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GT17573</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREXIGE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17713</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>90 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>375 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>500 MG/D</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03369</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071006233</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13965421</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>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugauthorizationnumb>019884</drugauthorizationnumb>
        <drugdosagetext>CYCLE1,2 AND 3:21-NOV-2006TO 24-NOV-2006,11-DEC-2006 TO 16- DEC-2006 AND 8-JAN-2007 TO L2-JAN-2007 .</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13439187</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0667987A</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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS ULTRA TABLETS, ASSORTED FRUIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505184-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13966155</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13952866</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505186-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW23683</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>84.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW08801</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25081</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>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW09506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
        <drugtreatmentduration>1413</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>20.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW22257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21144</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>77.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE ANTIHYPERTENSIVE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW23893</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>
      <patientweight>109.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>900 MG TO 1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>900 MG TO 1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW22468</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW19367</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>300 TO 400 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW14915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15887</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25 - 50 MG; QD - BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060528</drugenddate>
        <drugtreatmentduration>544</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW22545</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>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>50 MG QAM AND 200 MG HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TYCO HEALTHCARE/MALLINCKRODT-T200701241</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>100 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25036</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-526885</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>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 3 MG/ 3 ML, PATIENT TOOK 2 INJECTIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS 'DONNATOL EXTEND TABS'</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071005917</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071006074</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070107483</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>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>06F082P1</drugbatchnumb>
        <drugdosagetext>8 DOSES PRIOR TO BASELINE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070504252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</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>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>DOSE 4G/9G DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250033</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>541</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422225-00</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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-249670</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK238650</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US242520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710662BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>18181</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SOFRADEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OTITIS EXTERNA CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713088BCC</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>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RID LICE SHAMPOO</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LICE INFESTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RID LICE SHAMPOO</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RID HOUSEHOLD SPRAY</medicinalproduct>
        <drugindication>LICE INFESTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086569</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713500BCC</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>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEO-SYNEPHRINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE HCL TOPICAL SOLUTION 4%</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE W/ EPINEPHRINE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>15 MG, SINGLE</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 TABLET, 3/WEEK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL245422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086301</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249131</companynumb>
    <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P084107</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248875</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007331</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>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugindication>GENERAL PHYSICAL CONDITION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070804598</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>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>800/200MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <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>MK-0518</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200700165</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084951</drugauthorizationnumb>
        <drugdosagetext>.3 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E                          /00110501/</medicinalproduct>
        <drugdosagetext>200 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN   /00831701/</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200700834</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>MENEST</medicinalproduct>
        <drugauthorizationnumb>084951</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084951</drugauthorizationnumb>
        <drugdosagetext>.3 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200700956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084950</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC   /00661201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN                           /00917501/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200500229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugbatchnumb>16325</drugbatchnumb>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.3 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.3 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugbatchnumb>31290</drugbatchnumb>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugbatchnumb>30021</drugbatchnumb>
        <drugauthorizationnumb>084948</drugauthorizationnumb>
        <drugdosagetext>.625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL                           /00428402/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOYAMOYA DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.7 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247742</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>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>387 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006140</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>22106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712164BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713009BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <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>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 440 MG  UNIT DOSE: 220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2002JP01244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011220</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18002</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071002145</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250376</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>019676</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK TABLET, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACQUIRED HAEMOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-WYE-H00993707</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>KLEBSIELLA INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706121</drugbatchnumb>
        <drugdosagetext>100MCG AND 25 MCG PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706121</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070801267</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugdosagetext>HALF PATCH AREA COVERED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071002113</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>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505257-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20070602676</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugauthorizationnumb>062477</drugauthorizationnumb>
        <drugdosagetext>IN THE MRONING AND EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>IN THE MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PROLACTIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS TURBUHALER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5505259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00815607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>67.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORPLANT SYSTEM</medicinalproduct>
        <drugauthorizationnumb>020088</drugauthorizationnumb>
        <drugdosagetext>6 CAPSULES</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5505260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100408</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>PARTIAL SEIZURES</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>VOMITING</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEER</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505261-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070801817</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>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-06P-144-0330120-01</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20050225</drugstartdate>
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        <drugenddate>20060227</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>19900101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870501</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20000120</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20000514</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000708</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCEVITA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEROID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900520</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900520</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505264-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007RR-10918</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>MALLORY-WEISS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505265-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
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    <companynumb>US-RANBAXY-2007RR-10917</companynumb>
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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>COLITIS ISCHAEMIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
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  <safetyreport>
    <safetyreportid>5505266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
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    <companynumb>IT-RANBAXY-2007RR-10879</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMESULIDE RANBAXY 100MG GRANULATO PER SOSPENSIONE ORALE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOLO RANBAXY 120MG/5ML SOLUZIONE ORALE</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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      <reportercountry>ITALY</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLINA RANBAXY 1 G COMPRESSE SOLUBILI</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
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  <safetyreport>
    <safetyreportid>5505269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071007813</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>070327077</drugbatchnumb>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugbatchnumb>070327077</drugbatchnumb>
        <drugauthorizationnumb>020516</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20071006960</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071005318</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugdosagetext>2  TIMES 100MG TABLETS TAKEN TWICE A DAY FOR TWO MONTHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505275-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-KINGPHARMUSA00001-K200701400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>0.5 CM3 OF 1:1,000, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>0.5 CM3 OF 1:10,000, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>0.5 CM3 OF 1:100,000, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505276-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006108</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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBERAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007254</companynumb>
    <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 FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007386</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>
      <patientweight>83.01</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007414</companynumb>
    <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>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007462</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070304729</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060814</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMOSTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070905590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071001133</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070902003</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712440JP</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>
      <patientweight>57.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 12 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 8-12-10 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712851JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-07P-143-0422066-00</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>TDS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422009-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>484529A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467340</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>
      <patientweight>73.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAMARTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS ZITHROMAX.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>GENERIC REPORTED AS OXYCODONE W/APAP.  STRENGTH REPORTED AS 5/325.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473697</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>
      <patientweight>47.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>PRESCRIPTION WAS FILLED 6 TIMES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-527060</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE TAKEN FOR 14 DAYS FOLLOWED BY A 7 DAY REST PERIOD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-494048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN WAS REPORTED AS: 40 MG-AM/20 MG-PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>REPORTED AS: AZITHROMYCIN/Z-PACK.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>INDICATIONS FOR USE REPORTED AS: VAGINITIS/CERVICITIS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS: BID; INDICATIONS FOR USE REPORTED AS: VAGINITIS/CERVICITIS.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS: BID; INDICATIONS FOR USE REPORTED AS: VAGINITIS/CERVICITIS.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-527915</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugauthorizationnumb>018164</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 1 DOSE BID.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTAZOLIDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS BIPROFENID.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUCOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-523554</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>DOSAGE DECREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>20 MG IN THE MORNING AND 20 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0639383A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HEART VALVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY THORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PTERYGIUM COLLI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TURNER'S SYNDROME</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>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0673044A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>07?117P</drugbatchnumb>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0685970A</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690325A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690652A</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>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>3.2MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690798A</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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERA-FLU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691115A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691284A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugauthorizationnumb>020236</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691288A</companynumb>
    <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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0362059F</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>132.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TRIAL MEDICATION</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
        <drugtreatmentduration>916</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0423888A</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>9MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0436579A</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>21003</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VIRAL HEPATITIS CARRIER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060803</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060803</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICAL HORMONE PREPARATIONS</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060808</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA NICOTINATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0438744A</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>43</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060913</drugenddate>
        <drugtreatmentduration>282</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
        <drugtreatmentduration>315</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMOBOLAN</medicinalproduct>
        <drugdosagetext>4TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>4TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR VERTEBRAL FRACTURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>4TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0456621B</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0484467A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFORMIN</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWINRIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWINRIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIMAX</medicinalproduct>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>150MG IN THE MORNING</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIVONEX</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>3MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYMADON</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGOCORT CREAM</medicinalproduct>
        <drugindication>DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugdosagetext>25MCG TWO TIMES PER WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486130A</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>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061025</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505315-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486215A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505316-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487863A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488135A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>3150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488416A</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>76.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>30IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>14IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505319-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489928A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>175MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490416A</companynumb>
    <primarysource>
      <reportercountry>LITHUANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491447A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492091A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELONTRIL</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANKIMAZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493009A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>20548</drugauthorizationnumb>
        <drugdosagetext>400MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493297A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493509A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21254</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493530A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugdosagetext>6TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493623A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493643A</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugauthorizationnumb>21003</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493649A</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>
      <patientweight>153</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493656A</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>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>8MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONOCLONAL ANTIBODY</medicinalproduct>
        <drugbatchnumb>LOO5950</drugbatchnumb>
        <drugdosagetext>6MGK PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>20MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFFINE LIQUIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493744A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-527840</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FREQUENCY ILLEGIBLE. DOSAGE FORM REPORTED AS SYRINGES.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-506522</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>51</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-524360</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>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-522918</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-511771</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DRUG REPORTED AS XELODA 300</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>DOSAGE ADJUSTED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS AMOBAN TABLETS 7.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS NITROPEN.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DO-ROCHE-512120</companynumb>
    <primarysource>
      <reportercountry>DOMINICAN REPUBLIC</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION PARASITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-527595</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED: INJECT</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-522993</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20061206087</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GYNO-DAKTARIN</medicinalproduct>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GYNO-DAKTARIN</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006593</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFENPRODIL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPERISONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURSULTIAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVIN ADENINE DINUCLEOTIDE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-470037</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>92.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0092-01</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0092-01</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>B0092-01</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSE WAS INCREASED TO 1200 MG DAILY ON AN UNSPECIFIED DATE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>U6006</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON 03 JUNE 2006 DOSE WAS INCREASED TO 40 MG/DAILY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>ON 13 MAY 2006 DOSE WAS REDUCED TO 175 MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS SLIDING SCALE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>STOPPED 01 MAY 2006 AND RESTARTED 17 AUGUST 2006 AT DOSE OF 20ML.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-522288</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-505350</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>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>0077871, C212714</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN TWICE DAILY ON DAYS ONE TO FOURTEEN OF EVERY THREE-WEEK-CYCLE (FROM PM OF DAY ONE TO AM OF DA+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAY ONE OF EVERY THREE-WEEK-CYCLE. FORM REPORTED AS INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLANTAGO OVATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>REPORTED AS IRON (FE).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>TDD ILLEGIBLE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugdosagetext>REPORTED AS MEDAMIZOL.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANIL</medicinalproduct>
        <drugdosagetext>REPORTED AS PHENTANILE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 16 / 2 G</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>TAKEN AS NEEDED.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006774</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070305451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN PUMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-526073</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>
      <patientweight>112.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070107094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505357-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070401624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051000848</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071006123</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugauthorizationnumb>19735</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOXIN</medicinalproduct>
        <drugauthorizationnumb>019735</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071006683</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071004698</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugdosagetext>FOR 6 MONTHS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710007451</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1400 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GALLBLADDER CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710006919</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710006485</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELOCATIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710006888</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</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>20061215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>283</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710006112</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ELI_LILLY_AND_COMPANY-IN200710005210</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A327296</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>12 IU, EACH MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>8 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARKAMIN</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEM</medicinalproduct>
        <drugdosagetext>18 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710005808</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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE200707004270</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>DAY 1 AND DAY 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DAY 1 OF EVERY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710000585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.678</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON                                /CAN/</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugdosagetext>8 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>100 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ELI_LILLY_AND_COMPANY-NO200710005446</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>UNK, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00519207</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE935404AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE996926MAY05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505384-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOXACILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRUSH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070806626</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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505387-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THINKING ABNORMAL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070902846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070702673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505392-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505394-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008194</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>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505396-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA03616</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>BLOOD CREATININE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</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>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA02015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</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>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0707USA02705</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAPID EYE MOVEMENTS SLEEP ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>12703</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012703</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012703</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012703</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC DR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA04073</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>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMUS TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05066</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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAILURE OF IMPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505401-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA04148</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>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROTINOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILSICAINIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0611SWE00003B1</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUCTUS ARTERIOSUS PREMATURE CLOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05997</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugauthorizationnumb>013400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESYLATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN HUMAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA02153</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05390</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA00690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0611SWE00003M</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06316</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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0703USA03476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00979507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029883</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PCP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW18485</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>
      <patientweight>88.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ASTRAZENECA-2007SE05726</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12609</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
        <drugtreatmentduration>339</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROX</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATIL</medicinalproduct>
        <drugdosagetext>1600 MG</drugdosagetext>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISCORDINOL</medicinalproduct>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029852</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>75 MCG/KG, UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US244874</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713029BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 81 MG  UNIT DOSE: 81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-249893</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DF, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0420414-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>ENDED WHEN THE PATIENT WAS HOSPITALIZED</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0422351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-246240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE804215OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE812215OCT04</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>20527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA_2007_0029870</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA_2007_0029869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDEP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOTEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-244087</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE812515OCT04</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13964390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugauthorizationnumb>050443</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13964432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugauthorizationnumb>050443</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED  FORM 175 MG/M2 TO 215 MG/M2 AND THEN TO 250 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13960273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13938089</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>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugauthorizationnumb>021183</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13964424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
        <drugdosagetext>1.2 G/M2 ON DAYS 2 AND 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>050443</drugauthorizationnumb>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>DAYS 2 AND 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>175 MG/M2 ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTICULAR GERM CELL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13960810</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-0700293US</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>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>017011</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</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>5505447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.039</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>M92082</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>P538202, 1848001</drugbatchnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071005817</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-07P-007-0422752-00</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422067-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugdosagetext>SYSTEMIC (NOT SPECIFIED)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP02212</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</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>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP09581</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE TRIMMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006BE06867</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>
      <patientweight>73.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT VITAMINE D3</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003383</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 10 MG</medicinalproduct>
        <drugbatchnumb>138244</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006130</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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugbatchnumb>JVO7006</drugbatchnumb>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID COMPLETE</medicinalproduct>
        <drugbatchnumb>JVO7006</drugbatchnumb>
        <drugauthorizationnumb>020958</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20070100468</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GYNO-DAKTARIN</medicinalproduct>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GYNO-DAKTARIN</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007309</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007743</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070904137</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFFIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006779</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505482-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0002903</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugauthorizationnumb>88584</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugdosagetext>.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0002903</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugdosagetext>.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0420727-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505485-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0372292-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</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>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA-ACETATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA-ACETATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM PHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOCATRIOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITARENAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOL OIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHORB-MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505486-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-06P-167-0330675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061203609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505490-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20041204127</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>25-25-50 MCG</drugdosagetext>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HN-ROCHE-527337</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029928</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GB00503</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE02880</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP15176</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</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>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP05463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR DENTAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
        <drugtreatmentduration>562</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAESTHETICS, LOCAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
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        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>888</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5505503-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-233587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR03346</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETROPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WAXY FLEXIBILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>7300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDAN TAB</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDAN TAB</medicinalproduct>
        <drugdosagetext>450 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>750 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505505-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2005JP17489</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>45 TO 90 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAS-108</medicinalproduct>
        <drugdosagetext>80 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>90720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIDOSIN</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>1000 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050215</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>130 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050614</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>120 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505506-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR01699</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugbatchnumb>R8018</drugbatchnumb>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA ^IPSEN^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505507-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-247510</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>750 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG, 2/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505508-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007TR04446</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1440 MG /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>175 MG /DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505509-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP22019</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>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOROIDAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOGT-KOYANAGI-HARADA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>40 MG/6.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505510-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007TR04446</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>175 MG /DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505511-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE12371</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTHESIS IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
        <drugtreatmentduration>1271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505512-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CH03080</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE MARSUPIALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE104809AUG04</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505514-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H00892607</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>300 UG/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1 G/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US09436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.142</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
        <drugtreatmentduration>77760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIASOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GENENTECH-250525</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>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-034748</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>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>15 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505524-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-036520</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.841</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>3/3/10/ THEN 30MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SHR-SE-2007-040621</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>135 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-002148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505527-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505528-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-040045</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505529-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040038</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>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039771</companynumb>
    <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>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505531-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-001912</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>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060306</drugenddate>
        <drugtreatmentduration>322</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060929</drugenddate>
        <drugtreatmentduration>193</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505532-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091687</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMYLASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505533-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-002255</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039795</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>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-004583</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>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA2759A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SHR-SE-2007-040577</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>130 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-SHR-NO-2007-040667</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-027292</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-027275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9497A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505541-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-037612</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>80.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8745A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG/D, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG/D, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAZADYNE</medicinalproduct>
        <drugdosagetext>12 MG/D, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>2.5 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>2 MG, BED T.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>80 MG/D, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>26 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugdosagetext>UNK, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1500 MG/D, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505542-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-025506</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>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLASTOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLASTOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>20 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>50 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugdosagetext>750MG-7.5MG, EVERY 6H, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID-FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>500MG-105MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 A?G/ML, 1X/MONTH</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007090174</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:0.5MG DAILY  TDD:0.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:0.5MG BID  TDD:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1MG BID  TDD:2MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDOXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2007090169</companynumb>
    <primarysource>
      <reportercountry>PERU</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ASTRAZENECA-2007SE05761</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugbatchnumb>IA2538</drugbatchnumb>
        <drugauthorizationnumb>071202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-ADRENOLYTIC DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06799</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>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE INJECTION</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW13041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100 MG, 200 MG, 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06605</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21079</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06611</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugdosagetext>60 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWNDRUG</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06767</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED IN DIVIDED DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06739</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE HYDROCHLORIDE PRESERVATIVE FREE</medicinalproduct>
        <drugauthorizationnumb>70553</drugauthorizationnumb>
        <drugadministrationroute>029</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>1% DIPRIVAN INJECTION</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505552-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25337</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>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505553-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06737</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>EXTRADURAL HAEMATOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>018304</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06244</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>
      <patientonsetage>21236</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>PATIENT MISSED SOME DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>PATIENT MISSED SOME DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>PATIENT MISSED SOME DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCARON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW23942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06759</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>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN INJECTION</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02165</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>
      <patientweight>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SECONDARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>270</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505559-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17189</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>101.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25MG TO 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</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>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DSS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1 - 2 TAB Q6 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505560-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089617</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>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/MAGNESIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007083015</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DILATATION INTRAHEPATIC DUCT ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETALAR</medicinalproduct>
        <drugauthorizationnumb>16812</drugauthorizationnumb>
        <drugdosagetext>TEXT:4 MG/ML-FREQ:1-6 ML/HOUR INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHISTERONE TABLET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:70MG-TEXT:70 MG DAIILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:300MG-TEXT:300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>FREQ:CONTIUES INTRAVENOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEMOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>169.54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONGENITAL TRICUSPID VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007062753</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2007082274</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2006025443</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505568-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-GENENTECH-250642</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>ANTERIOR CHAMBER INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.1 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007049246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AG-013,736</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>TEXT:650MG BOLUS + 1980MG X2 DAYS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>TEXT:500MG BOLUS + 1525MG X2 DAYS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCEAN NASAL SPRAY</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW24893</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25306</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW24962</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARADOIS H</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006138906</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPROSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13966577</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007072682</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>71.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:0.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250589</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>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13965835</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13959549</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13960653</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13889498</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugdosagetext>AUC 5; FIRST INFUSION AND MOST RECENT INFUSION: 2-AUG-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION: 02-AUG-2007; MOST RECENT INFUSION: 09-AUG-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13965124</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>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>STRENGTH 2MG/ML.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13964416</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0418844-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0354376-01</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</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>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL FUNCTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2006057414</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDRALAZIN</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCADOR</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505586-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422151-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6</patientweight>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>175-200 MICROGRAMS/KG/MIN</drugdosagetext>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugindication>INTUBATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1-4 MICROGRAMS/KILOGRAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422073-00</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>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELBAMATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505588-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006027750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA ANNULARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505589-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-250582</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1101 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METADON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOPRIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010822</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060719</drugenddate>
        <drugtreatmentduration>1602</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
        <drugtreatmentduration>196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
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        <drugstartdate>20010601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>FREQ:ONCE TO TWICE PER DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000929</drugstartdate>
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        <drugenddate>20060101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010208</drugstartdate>
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        <drugenddate>20040801</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505591-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2005093551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:40MG-FREQ:DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
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        <drugenddate>20031001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
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      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>63.991</patientweight>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1006 MG, Q3W</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>5505593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006150490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020103</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
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        <drugenddate>20030801</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020114</drugstartdate>
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        <drugenddate>20030314</drugenddate>
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  <safetyreport>
    <safetyreportid>5505594-0</safetyreportid>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</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>
      <patientweight>87.1</patientweight>
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        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
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        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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    <safetyreportid>5505595-2</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <receiver></receiver>
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        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5505597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007024907</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEP AID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007012302</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>008697</drugauthorizationnumb>
        <drugindication>ADDISON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007007516</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021968</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007083511</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG-FREQ:DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007048009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLLICULAR THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTROLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007047780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2007087230</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
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      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANTIINFECTIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>FREQ:2 TABS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007042163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007036881</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007014658</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DAYDREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-BRISTOL-MYERS SQUIBB COMPANY-13941505</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007057569</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021968</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007083617</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBOHALER</medicinalproduct>
        <drugdosagetext>TEXT:400 UG-FREQ:2 INTAKES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugdosagetext>TEXT:2 INHALATIONS-FREQ:2-4 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>FREQ:2 INTAKES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>FREQ:2 INTAKES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>FREQ:3 PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>TEXT:2 PUFFS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugdosagetext>TEXT:40</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>TEXT:1000-FREQ:3 PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089040</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007053575</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25339</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>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW21159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25360</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS GRAFT THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ASTRAZENECA-2007UW25056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>492</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25148</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
        <drugauthorizationnumb>018760</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>}1 YEAR</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007061202</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>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:60MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007083782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>AW9558529</drugbatchnumb>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROSPIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007051543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:9MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>N53568</drugbatchnumb>
        <drugdosagetext>0.6 UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINOLONE ACETONIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR OINTMENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007050918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>280 MG/M2, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>140 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>S-1 (TS-1) (TEGAFUR, GIMERACIL, OTERACIL POTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0422716-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</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>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>163.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:180MG-TEXT:BID EVERY DAY TDD:180MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007064431</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugbatchnumb>50425,70115,70113</drugbatchnumb>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:7MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:9I.U.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:75MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089430</companynumb>
    <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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:600MG-FREQ:EVERYDAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007062262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007084740</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFORTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALNUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505628-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-PFIZER INC-2007088597</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.181</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:300MG-FREQ:EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:400MG-FREQ:DAILY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007058921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007055183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEOSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089352</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONAL PERCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>TEXT:10MG</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS AND IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007067084</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>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURNAL DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089405</companynumb>
    <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007065619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>TOBACCO ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422081-00</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>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLEZAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>144.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>10413</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>TEXT:6.25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-527763</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>180 UG PER WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007072373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED LINEZOLID</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>TEXT:15-30 ML-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>TEXT:1/150 1 TAB-FREQ:Q 5MIN X 3DOSES</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>TEXT:5-10MG-FREQ:Q6H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007072342</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>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007071707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007070584</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECTISOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089206</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>173.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089496</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOB DISSATISFACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089209</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074758</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20050400473</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>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLINSAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOSTEP</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007074362</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>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FURUNCLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>TEXT:EVERY DAY</drugdosagetext>
        <drugindication>FURUNCLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007073762</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007073268</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:180MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLOVENIN I</medicinalproduct>
        <drugdosagetext>TEXT:12.5G; 2G/KG</drugdosagetext>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T3 INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082725</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007089407</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007072887</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>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422189-00</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM WITH LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESSOR VISION</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0371490-00</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTRIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PEN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YEAST DRIED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YEAST DRIED</medicinalproduct>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBERTOSE</medicinalproduct>
        <drugindication>IMMUNE ENHANCEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROP</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007077036</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-07P-229-0367988-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>143</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0421740-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-LYSINE ACETYLSALICYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSTERENE SODIUM SULFONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>52-405-PK,54-353-DK</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CALCIUM METABOLISM DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>52-405-PK,54-353-DK</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHOSPHORUS METABOLISM DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0422014-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACLADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINES-B-LABAZ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINAPHTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0421923-00</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>EPILEPTIC AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE DE SODIUM WINTHROP LP TABLET PR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVERAL CONCOMITANT DRUGS NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0421827-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</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>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422271-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0422005-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESMOLOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13958137</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>REDUCED TO 200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007075396</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM FOR INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:25MG-FREQ:PRN</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMETHOLON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:125MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007075984</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOLEVURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-248253</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007075436</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007075905</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-247975</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 UNIT, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007075052</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007079995</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>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTRADIOL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-CLINOVIR</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007078940</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugdosagetext>TEXT:2 DF</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007079147</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245475</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>77.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX SOLUTION</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007080152</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007077216</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.968</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N38279</drugbatchnumb>
        <drugdosagetext>536 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>149 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-2007078851</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007083521</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:75MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2500MG</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:480MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007086222</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>BENIGN NEOPLASM OF THYROID GLAND</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250597</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>208 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>87 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINE HYDROCHLORIDE INJ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID REPLACEMENT</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE NASAL SPRAY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-PFIZER INC-2007084280</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAOCULAR MUSCLE PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX - SLOW RELEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM-ACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007083355</companynumb>
    <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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007083173</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250305</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082999</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007083096</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>010392</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:125MG-TEXT:125 MG SINGLE DOSE-FREQ:ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082849</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYARI BACTERIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC PREPARATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESIC FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:120MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LISDEXAMFETAMINE DIMESYLATE</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007081172</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249551</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>76.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>6 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 MG/ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007086743</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200706021</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086469</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>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200710316</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>797</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEW LECICARBON</medicinalproduct>
        <drugdosagetext>1-2 DOSE FORM PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0372233-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422755-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL 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>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINIUM CHLORHYDROXIDE-COMPLEX</medicinalproduct>
        <drugdosagetext>2-3-2</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOTRIOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007086320</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>010392</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:525MG-TEXT:525 MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0422072-00</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>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0422065-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0422530-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</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>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200711905</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200711527</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPICOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPICOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2007085727</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACURETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-SYNTHELABO-A01200711998</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVENCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMALYT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MASDIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200712050</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPICOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007085607</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>OSTEOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089208</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706133</companynumb>
    <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>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706065</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>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200700037</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089203</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-D01200707428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>300 MG (+PLACEBO) D1 FOLLOWED BY 75 MG (+PLACEBO) D2 TO D7; 75 MG FROM D8 TO 30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA HIGH DOSE</medicinalproduct>
        <drugdosagetext>AT LEAST 300 MG D1; 300-325 MG FROM D2 TO D30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>600 MG LD D1 FOLLOWED BY 150 MG FROM D2 TO D7; 75 MG FROM D8 TO 30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706172</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>TOOK ^40 MM^ OF ZOLPIDEM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200701345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-F01200701393</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>1/2 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>553</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200701100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-250396</companynumb>
    <primarysource>
      <reportercountry>LEBANON</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>700 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087517</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-F04200700081</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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLIN</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-SANOFI-SYNTHELABO-F01200701403</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007087510</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECALL PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087420</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHISTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087405</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>SOLANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</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>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007087196</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTROCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (NEEDS NO REFRIGERATION)</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007088925</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125</patientweight>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCTACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:300MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711882US</companynumb>
    <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>HYPOAESTHESIA EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugbatchnumb>46320</drugbatchnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugbatchnumb>49417</drugbatchnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugbatchnumb>49529</drugbatchnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0419728-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0422049-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</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>20070314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHARATED IRON OXIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARNITINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARNITINE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088861</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYCARBOPHIL CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007088816</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088716</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:160MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-0712048US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</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>ALESION SYRUP</medicinalproduct>
        <drugauthorizationnumb>21565</drugauthorizationnumb>
        <drugdosagetext>10 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007088671</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088327</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007088227</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250343</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087639</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPRODONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVINE ADENINE DINUCLEOTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007089406</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOBRIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089397</companynumb>
    <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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007089401</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>POLYMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORFON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089396</companynumb>
    <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>PHENYTOIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089239</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>CONVULSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0333266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHORDEE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <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>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-ABBOTT-07R-008-0364834-00</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>BERACTANT</medicinalproduct>
        <drugdosagetext>OTHER = ML/KG</drugdosagetext>
        <drugadministrationroute>007</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422104-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19892</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-07P-013-0421912-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-07P-143-0422064-00</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>2</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLACEE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM-C</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTROXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONKESE-CO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089223</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007088951</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugbatchnumb>15607V</drugbatchnumb>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugbatchnumb>15607V</drugbatchnumb>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089507</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-246408</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>520 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422714-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</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>20060619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUMACETAT NEFO 500 MG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENARGEL 800 MG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOLOX 10 MG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0420697-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250580</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.9 ML, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0422068-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACLADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0371629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PAPILLARY MUSCLE RUPTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PAPILLARY MUSCLE RUPTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0376686-00</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089492</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007089451</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:120MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAPRESSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089444</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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-DE-06358GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-22883RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23611RO</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>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23478RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD THICKENING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>76504</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYMYXIN B</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23481RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>074069</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>070433</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23480RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077262</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23479RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>021648</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>070433</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22426BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17564YA</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN OCAS</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSORBIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23315BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22231BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23563BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704577A,7C2222</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22297SG</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELMISARTAN CAPSULES</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC TABLETS 15 MG</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLARBIPROFEN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23613BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23618BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23620BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23425BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23422BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22433BP</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23745YA</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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23619BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21228BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</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>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOSYN</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA ER</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARCOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23575BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22391BP</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>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET AGGREGATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOCALIN</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22389BP</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>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22606BP</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>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-05623BP</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>653523</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2004-BP-05290BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-FF-00937FF</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>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CYST BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>718639</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>REPORTED IN THE NARRATIVE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>718639</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-FF-00901FF</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>BRONCHIAL OBSTRUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE ROUSSEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRLIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALIEN CERAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22210BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505817-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22277BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22276BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22275BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22274BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22734BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22735BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089421</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007089402</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EDRONAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTIZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200711458</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.727</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT LIFE THREATENING EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN 10GR TIMED DISINTEGRATION TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US16451</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>
      <patientweight>57.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089551</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089696</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089669</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089643</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089606</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007089601</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007089603</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050710</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089592</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>TEXT:1 DF-FREQ:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugdosagetext>TEXT:1.25 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>TEXT:1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>TEXT:1DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03157</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUSTER HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>5MU</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>2692</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089886</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089866</companynumb>
    <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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089857</companynumb>
    <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.454</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089783</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19650101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089740</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugbatchnumb>CD70834E</drugbatchnumb>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THOMAPYRIN N</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089734</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>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS HERPETIFORMIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422273-00</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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0326143-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0418477-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</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>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URAEMIC PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0422332-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421737-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422703-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</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>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHAT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOTRIOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0422746-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AIDS RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugdosagetext>400/100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422211-00</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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090087</companynumb>
    <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>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090078</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>INHALED HUMAN INSULIN</medicinalproduct>
        <drugauthorizationnumb>21868</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090082</companynumb>
    <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>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007090056</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05664</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0609USA01253</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980315</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
        <drugtreatmentduration>2637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980315</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060224</drugenddate>
        <drugtreatmentduration>2637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELESTROGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00002</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0710AUS00290</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0710POL00025</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</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>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA00304</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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA02284</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>MULTIPLE SYSTEM ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA00300</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTIGMINE BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEQUITAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090039</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>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA04732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>143</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505875-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0710GBR00130</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugauthorizationnumb>018086</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0708GBR00022</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA05847</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>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505878-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05066</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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAILURE OF IMPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-PFIZER INC-2007089970</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAMAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505880-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-247690</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50 MG, X5</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007090103</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090324</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0186</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1MG BID EVERYDAY TDD:2MG</drugdosagetext>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>TEXT:400MG</drugdosagetext>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>TEXT:50MG</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505884-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090278</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugauthorizationnumb>020771</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505886-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090259</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>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIOLYTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090231</companynumb>
    <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250644</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090223</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>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090182</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090152</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505893-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090132</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAIL BED BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090128</companynumb>
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      <reportercountry>SPAIN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505895-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090126</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PERICARDITIS INFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
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        <drugstartdate>20070903</drugstartdate>
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        <drugenddate>20070901</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5505896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-PFIZER INC-2007090494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505897-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090491</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>MANIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5505898-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090404</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
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    <companynumb>US-PFIZER INC-2007090422</companynumb>
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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>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
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        <drugindication>SMOKING CESSATION THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505900-7</safetyreportid>
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    <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505901-9</safetyreportid>
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    <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>
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        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5505902-0</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5505903-2</safetyreportid>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5505904-4</safetyreportid>
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      <reportercountry>CANADA</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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        <reactionmeddrapt>COUGH</reactionmeddrapt>
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        <medicinalproduct>SPIRIVA</medicinalproduct>
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        <medicinalproduct>ALBUTEROL</medicinalproduct>
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        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
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        <medicinalproduct>LIPITOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091219</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>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091007</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505912-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-2007090754</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>021434</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>021434</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESIL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESIL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAFEN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505913-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090750</companynumb>
    <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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505914-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090719</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1 MG BID EVERY DAY TDD:2 MG</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090697</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090667</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2007090651</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>DAILY DOSE:150MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2.5MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091579</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250205</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>275 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091290</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CP-195,543-90</medicinalproduct>
        <drugbatchnumb>05-032186</drugbatchnumb>
        <drugauthorizationnumb>72457</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugbatchnumb>05-032189</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US09436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.142</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
        <drugtreatmentduration>77760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIASOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE12371</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTHESIS IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
        <drugtreatmentduration>1271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18002</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006657</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312114</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505928-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006282</companynumb>
    <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 MIGRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505930-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708006174</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>POLYNEUROPATHY IDIOPATHIC PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A313836</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </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>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006393</companynumb>
    <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF6E70A</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710000234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A324158</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXAT</medicinalproduct>
        <drugdosagetext>12.5 MG, WEEKLY (1/W)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY (1/W)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50000 U, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HCL</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710005908</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 TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311536</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>552</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, COMBINATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006325</companynumb>
    <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>FOREIGN BODY ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A327071</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710003620</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311536</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 U, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311536</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071103</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006416</companynumb>
    <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 INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A324738</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715041GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715044GDS</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715042GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18118</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALVUS MET</medicinalproduct>
        <drugdosagetext>100 MG + 850 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14229</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>41.723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS AND IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN /UNK/</medicinalproduct>
        <drugdosagetext>ON SUNDAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN W/GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050726</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>787</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLASTOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02041</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TR18215</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17997</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DE17750</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVIDEL</medicinalproduct>
        <drugauthorizationnumb>17962</drugauthorizationnumb>
        <drugdosagetext>2.5MG , ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02518</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>32 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>125 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>06C00233B</drugbatchnumb>
        <drugdosagetext>9441 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>112 MCG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugbatchnumb>BE6824317</drugbatchnumb>
        <drugdosagetext>10MG. TAB 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>A 21</drugbatchnumb>
        <drugdosagetext>5 MG 1 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE958008JUL04</companynumb>
    <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 METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE112715JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE139426MAR04</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>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-G00547507</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>EVERY THREE WEEKS IN CYCLES</drugdosagetext>
        <drugindication>NEPHROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>EVERY 3 WEEKS IN CYCLES</drugdosagetext>
        <drugindication>NEPHROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE183411AUG04</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00539707</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>150MG FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>500UG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125UG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>5MG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>25MG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEARS NATURALE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>120MG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>1.16%</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100UG FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE155612JUL05</companynumb>
    <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>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENIC SUBSTANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE141628MAY04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</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>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE181311AUG04</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>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP12869</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugdosagetext>2 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.643</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBAL LIGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAR DYSPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625/2.5 MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE BROMIDE</medicinalproduct>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE HCL 1PC SOL</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTIGMIN /GFR/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE17547</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>2880 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007HK16572</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PTK787</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN EBEWE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02005</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT18188</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDACTEROL VS FORMOTEROL VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TW02872</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE17758</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050737</drugauthorizationnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02043</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>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>FETAL DRUG EXPOSURE VIA FATHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006IE17693</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/KG/DAY</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>3.5 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03196</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>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</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>OXYNORM</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18059</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EN000104</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>400 MG;QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugdosagetext>36 GM ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO SDF</medicinalproduct>
        <drugdosagetext>3500 MCG 1 TIME IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03457</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR PULMONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>ONCE A WEEK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugdosagetext>1 DOSE 1 TIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03510</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/COLECALCIFEROL (COLECALCIFEROL, CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>1.2 MG Q1H PRN IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG X1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>8MG X1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG X1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505992-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03556</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.60 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGADRONE (DEXAMETHASONE SODIUM PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN (PENTETHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM (WARFARIN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN (TULOBUTEROL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE FOR INHALATION (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505993-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>95.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60MG/M2 1 Q 3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600MG 1 Q 3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOV-002</medicinalproduct>
        <drugdosagetext>60MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>500MG OD 1 TAB OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505995-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03561</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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03562</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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugbatchnumb>JC67</drugbatchnumb>
        <drugdosagetext>THREE TABLETS TWO TIMES DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5505999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugdosagetext>20 MG ONE BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugdosagetext>20 MG ONE BID</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB,25MG/ML,GENETECH</medicinalproduct>
        <drugdosagetext>816 MG Q 2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03563</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>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>141.9759</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>30 ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>30 ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>30 ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>30 ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG 4 X DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>82.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A370884</drugbatchnumb>
        <drugdosagetext>500MG/M2 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A370884</drugbatchnumb>
        <drugdosagetext>500MG/M2 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A370884</drugbatchnumb>
        <drugdosagetext>500MG/M2 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>1156982</drugbatchnumb>
        <drugdosagetext>AUC=5 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>1156982</drugbatchnumb>
        <drugdosagetext>AUC=5 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>1156982</drugbatchnumb>
        <drugdosagetext>AUC=5 EVERY 21 DAYS IVPB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03564</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>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600 MG Q12H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-266961</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN NN729</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>18 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN NN729</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>15 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>2.3MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>107MG IV  ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0665</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugdosagetext>500 MG Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0058C-A</drugbatchnumb>
        <drugdosagetext>10MG DAILY X21D/28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056C-B;0059C-</drugbatchnumb>
        <drugdosagetext>5MG ALTERNATE WITH 10MG QOD X21D/28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugdosagetext>40 MG Q8H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 100MG/50ML IMCLONE/BRISTOL MYERS SQUIBB</medicinalproduct>
        <drugbatchnumb>06C00764B</drugbatchnumb>
        <drugdosagetext>493MG -250MG/M2- WEEKLY -2ND DOSE- IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 100MG/50ML IMCLONE/BRISTOL MYERS SQUIBB</medicinalproduct>
        <drugbatchnumb>06C00764B</drugbatchnumb>
        <drugdosagetext>493MG -250MG/M2- WEEKLY -2ND DOSE- IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 100MG/50ML IMCLONE/BRISTOL MYERS SQUIBB</medicinalproduct>
        <drugbatchnumb>06C00764B</drugbatchnumb>
        <drugdosagetext>493MG -250MG/M2- WEEKLY -2ND DOSE- IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-165183-NL</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIDEPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#1#2007-00053</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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 OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>20649</drugauthorizationnumb>
        <drugdosagetext>60 MCG INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DIABETIC GANGRENE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE HEAVY (MAGNESIUM OXIDE HEAVY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAPEPTASE (SERRAPEPTASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM (BERAPROST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO MINOPHAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPLE</medicinalproduct>
        <drugdosagetext>10 MCG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETIC GANGRENE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>400,000 TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID BENADRYL DYE-FREE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6038979</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONGESCOR (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>1,25 MG ORAL (1, 25 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0,5 MG (0, 125 MG, 4 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE/SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>P-11662</drugbatchnumb>
        <drugdosagetext>800/160MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163111ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76162</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELITEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>172.3669</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1MG PRN OR DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1MG PRN OR DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200712681DE</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>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVASIN TAB</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC                              /00376903/</medicinalproduct>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT                               /01036501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLO</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712906JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AVENTIS-200614126GDDC</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 2 CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200711616JP</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>50.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN                            /00890701/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 30GY/TOTAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711198BVD</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>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIOVAN 160/12.5</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-200716400GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>21473</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL (SAP)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAYER-200716464GDS</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREDNISON 5 MG</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 3000 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGYL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 4 MG  UNIT DOSE: 1 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCI CHEW</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 600 MG  UNIT DOSE: 300 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1200 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163112ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>63097</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>80.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugbatchnumb>882026</drugbatchnumb>
        <drugdosagetext>15 MG. ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugbatchnumb>957809</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>20 MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG EVERYDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6038922</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>1, 25 MG (1, 25 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS (2 DOSAGE FORMS, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG EVERY OTHER DAY PO ; 2.5 MG EVERY OTHER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04223</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76426</drugauthorizationnumb>
        <drugdosagetext>500 MG TWICE A DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugdosagetext>50 MG TWICE A DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN (CASPOFUNGIN) (CASPOFUNGIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE (LORATADINE) (LORATADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL (PARACETAMOL) (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE (RANITDINE) (RANITIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYEDROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZTREONAM</medicinalproduct>
        <drugdosagetext>1 GRAM Q12H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>400 MG ONCE DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>865#9#2007-00012</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIDINOGENASE (KALLIDINOGENASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA BENSERAZIDE HYDROCHLO (BENSERAZIDE HYDROCHLORIDE, LEVODOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATETHINE (PANTETHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE (VOGLIBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAZOCHROME SODIUM SULFONATE (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF SENNA POD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11772</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>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02040</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12-450MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>3097</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03609</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG/D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17421</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFLASONE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEOLONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROLIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>10MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#5#2006-00430</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP ATTACKS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>12 MG/24H (12 MG/24H 1 IN 1 DAY(S)) TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUBIONATE (CALCIUM GLUBIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA, LEVODOPA (CARBIDOPA, LEVODOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE (SELEGILINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE, PARACETAMOL (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPSAICIN (CAPSAICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE POLYVALENT (INFLUENZA VIRUS VACCINE POLYVALENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOXICAN (TENOXICAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTACAPONE (ENTACAPONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAESTHETICS, LOCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE HYDROCHLORIDE (ORPHENADRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLACK CURRANT EXTRACT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1TAB BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>240MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-EUR-07-0148</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERMITTENT CLAUDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOFORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18073</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCADRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18068</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18072</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18314</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18076</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>23.1334</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIFORM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>08587V</drugbatchnumb>
        <drugdosagetext>10 MG CHEWABLE TABLET ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOMYOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTEROSALPINGO-OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>0.1 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugdosagetext>0.1 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MPA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US02782</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.1 MG TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugdosagetext>0.05 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625MG/2.5 MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>4 MG Q2-4H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17703</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP PHASE RHYTHM DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYO-KEI-ZYUTU-KAN-TO</medicinalproduct>
        <drugdosagetext>7.5 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>0.8 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14106</companynumb>
    <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>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>014130</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>0.25 MG. 3XWEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>325/30MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FR18112</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>175 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016910</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32005</drugbatchnumb>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32019</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022435</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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022467</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>129.2752</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17988</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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, 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>MINIPRESS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_26075_2005</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>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022475</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35026</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17916</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US17509</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC ALLOGRAFT NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18013</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>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GT18046</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</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>BIOPSY BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BREAST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEEDLE BIOPSY SITE UNSPECIFIED ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND BREAST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugdosagetext>0.1 MG/DAY, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010827</drugenddate>
        <drugtreatmentduration>569</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>0.1 %, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010815</drugenddate>
        <drugtreatmentduration>772</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10 MG, TEN DAYS OF EACH MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.1 MG/DAY UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991210</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugdosagetext>0.1 MG/DAY, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugdosagetext>1/20, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AYGESTIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000303</drugenddate>
        <drugtreatmentduration>77760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>1000 IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.167</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BREAST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugauthorizationnumb>020323</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>NIGHT SWEATS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>0.625 MG, QD</drugdosagetext>
        <drugindication>NIGHT SWEATS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2000 - 3000 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17702</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>76617</drugauthorizationnumb>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>05J25PA</drugbatchnumb>
        <drugdosagetext>270 MG Q3W IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYLAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022549</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022579</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>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>14896</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>JC VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugauthorizationnumb>71484</drugauthorizationnumb>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022585</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022586</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>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01099</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17688</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugdosagetext>480 MG OTH</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANDITINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022589</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32016</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32019</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000483</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>1 GM; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN INSULIN APPLICATOR: REGIMEN #1 (NO PREF. NAME)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATE (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022618</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022622</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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        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
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      <reportercountry>UNITED STATES</reportercountry>
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    <safetyreportid>5506102-0</safetyreportid>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>DASATINIB</medicinalproduct>
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        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
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        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
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        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>INITIATED AT DAILY DOSE 140MG/D THEN AT 100MG/D FROM MAR 2007</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
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    <primarysource>
      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>2</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>DESYREL</medicinalproduct>
        <drugauthorizationnumb>018207</drugauthorizationnumb>
        <drugdosagetext>DOSE:350MG DAILY THEN 400 MG THEN 350MG DAILY AND THEN DECREASED TO LOWER DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5506107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5506108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOMONOCYTIC LEUKAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACLACINON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5506109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13952825</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
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        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5506110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR NEOPLASM MALIGNANT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022676</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</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>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32024</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
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    <safetyreportid>5506113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>LATVIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>F019V05</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
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        <drugstartdate>20051014</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE QUANTITY: 1</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 200</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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    <receiptdate>20071024</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>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20060417</drugstartdate>
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        <drugtreatmentduration>3</drugtreatmentduration>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugdosagetext>1650 MG ON 07-MAR-2006 AND FROM 25-AUG-05 -60MG/KG</drugdosagetext>
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        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugdosagetext>1650 MG ON 07-MAR-2006 AND FROM 25-AUG-05 -60MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
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        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20060330</drugstartdate>
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        <drugtreatmentduration>3</drugtreatmentduration>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
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  <safetyreport>
    <safetyreportid>5506115-9</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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      <reaction>
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        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
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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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        <medicinalproduct>SIMVASTATIN</medicinalproduct>
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      <drug>
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        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <drug>
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    <serious>1</serious>
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    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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    <sender>
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    <patient>
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        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20070216</drugstartdate>
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    <safetyreportid>5506119-6</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientdeath>
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        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>DEFINITY</medicinalproduct>
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        <drugindication>ECHOCARDIOGRAM</drugindication>
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        <drugstartdate>20070131</drugstartdate>
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    <safetyreportid>5506120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
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    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13967872</companynumb>
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      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
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      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>020357</drugauthorizationnumb>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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      <drug>
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        <drugstartdate>20051004</drugstartdate>
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      <drug>
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        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
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      <drug>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
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  <safetyreport>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
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      <drug>
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        <drugstartdate>20030324</drugstartdate>
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      <drug>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
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        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
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      <drug>
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      <drug>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13440326</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022709</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>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP000327</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>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD(MICAFUNGIN INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>150 MG, D, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>60 MG, D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEM, CILASTATIN SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUN INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYGLOBIN (IMMUNOGLOBULIN HUMAN NORMAL, MALTOSE) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEPESID S (ETOPOSIDE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILDESIN (VINDESINE SULFATE) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA (HYDROXYCARBAMIDE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE (METHOTREXATE SODIUM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI002488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010167</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG;TWICE A DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>40 MG;DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1004676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>40 MG; TWICE A DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002397</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009359</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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E3810-01348-SPO-US</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>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASTRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713946BWH</companynumb>
    <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>LEVITRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MPS1-10767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>17.4 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074130</companynumb>
    <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>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09172</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76877</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>CYCLICAL, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FALLOPIAN TUBE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, CYCLICAL</drugdosagetext>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701376</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXERUTINS</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09079</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09097</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>18598</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN) SYRUP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM (CITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09131</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18303</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT KENEI</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPALRESTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02514</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18182</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL COMP.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>12/400 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09176</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCADIAN RHYTHM SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>18620</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC (ALLIUM SATIVUM) UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-15386507</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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>27319</drugbatchnumb>
        <drugauthorizationnumb>77062</drugauthorizationnumb>
        <drugdosagetext>ONE PATCH EVERY 72 HR, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>27319</drugbatchnumb>
        <drugauthorizationnumb>77062</drugauthorizationnumb>
        <drugdosagetext>ONE PATCH EVERY 72 HR, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>ONE PATCH EVERY 72 HR, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>ONE PATCH EVERY 72 HR, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09175</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76189</drugauthorizationnumb>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CC07-181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>0112007</drugbatchnumb>
        <drugauthorizationnumb>72273</drugauthorizationnumb>
        <drugdosagetext>2 ACTUATIONS AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM Q12H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-02877</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTRADIOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVULATION INDUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR DEPOT</medicinalproduct>
        <drugauthorizationnumb>20715</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1 IN 28D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
        <drugdosagetext>150 IU, 1 IN 1 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVIDREL</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18069</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17399</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>1.9 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14098</companynumb>
    <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>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DZ18112</companynumb>
    <primarysource>
      <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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17470</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANESTHETICS NOS</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AU16610</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>0.75 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>0.75 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US10850</companynumb>
    <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPIRONE T04670+CAPS</medicinalproduct>
        <drugdosagetext>7 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03195</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CH18309</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISMENOL N</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070331</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG Q4 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONCUSSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG Q4 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712870BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ZA17895</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>200 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US10491</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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugauthorizationnumb>20364</drugauthorizationnumb>
        <drugdosagetext>5/10 MG QD (AM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>ONE, QD (PM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30793_2007</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>94.8018</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGUS NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugbatchnumb>F7225</drugbatchnumb>
        <drugdosagetext>1 PILL DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY CHANGED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugbatchnumb>F7225</drugbatchnumb>
        <drugdosagetext>1 PILL DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.4838</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1X2 A DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1X2 A DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1X2 A DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>1X2 A DAY</drugdosagetext>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>1X2DAYS</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506170-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYEDROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US07321</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>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>0.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>77760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050735</drugauthorizationnumb>
        <drugdosagetext>25MG/EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506172-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>60.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL GENTLEHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM ADVANCED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRE-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004BR09351</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIODYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
        <drugtreatmentduration>1476</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>LEVEL 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>1442</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021016</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>LEVEL 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01723</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE</medicinalproduct>
        <drugdosagetext>WHOLE BODY SURFACE.</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-0712062US</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A UNK</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14220</companynumb>
    <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 STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18078</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FI17653</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MF EVERY THREE MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>900</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>1000</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17889</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02221</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
        <drugtreatmentduration>348</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061011</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugdosagetext>140 MG DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18013</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>URETERIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2007-02775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENACTRA</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2007-02803</companynumb>
    <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 X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>CONTINUOUS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1014MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>50MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELCLAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTOCOL MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMEBORO/BIAFINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>150MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>150MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1500MG BID IV QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRINSIC VASCULAR COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>150MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>150MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1500MG BID IV QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010015</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>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET (ETOPOSIDE)</medicinalproduct>
        <drugdosagetext>103 MG; INTRAVENOUS; DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET (ETOPOSIDE)</medicinalproduct>
        <drugdosagetext>103 MG; INTRAVENOUS; DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET (ETOPOSIDE)</medicinalproduct>
        <drugdosagetext>103 MG; INTRAVENOUS; DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>452 MG; DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>452 MG; DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>452 MG; DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>22UNITS BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714141BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00533007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</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>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE105109AUG04</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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01722</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL                (CLOBETASOL PROPIONATE)</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugdosagetext>WHOLE BODY SURFACE</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>875MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2007-0242</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>100 /25/200MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCORON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCORD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISGREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25233</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMOCONIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTASTHMATIC DRUG LEVEL THERAPEUTIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTASTHMATIC DRUG LEVEL THERAPEUTIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTASTHMATIC DRUG LEVEL THERAPEUTIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02176</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02211</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2007-0160</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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2007A05831</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPLIN SR                             FOR INJECTION KIT 11.25</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG (11.25 MG, 1 IN 12 WK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS                        (CANDESARTAN CILEXETIL) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX                          (BTCALUTAMIDE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS                        (NAFTOPIDIL) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701267</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200716517GDS</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB OR PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711200BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713508BCC</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>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRACAL CAPLETS + D TABLETS</medicinalproduct>
        <drugbatchnumb>6L049</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURE ESTER C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIRKLAND FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIRKLAND VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2007-0159</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>150 TDS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163379ISR</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETASONE</medicinalproduct>
        <drugauthorizationnumb>20911</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ    (FORMOTEROL FUMARATRE + BUDESONIDE)</medicinalproduct>
        <drugdosagetext>AS REQUIRED; RESPIRATORY INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOTIFEN FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506215-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03565</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>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-AVENTIS-200719932GDDC</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03566</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>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03567</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009367</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM IONISED DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>74587</drugauthorizationnumb>
        <drugdosagetext>6000 MG;X1;</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200612002200</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL                               /SWE/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>2070</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>1429</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX200710006808</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIFORM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707001823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOGRAM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL                              /00109201/</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA200710006813</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713489BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>250257H</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010204</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICOR /00802602/ (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext> ;DAILY;ORAL 5 MG;DAILY;ORAL; 10 MG;DAILY;ORAL; 5MG;EVERY OTHER DAY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010741</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77039</drugauthorizationnumb>
        <drugdosagetext>20 MG; ;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200707001090</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE W/TROPICAMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPHTHALMOLOGICAL EXAMINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA200710006815</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710006328</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPRODUCTIVE TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH200710005595</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UP TO 15 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>10 MG, 3/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>50 MG, EVERY 15 DAYS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>3 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707005215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.971</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL SOLUTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EN000107</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext> ;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EN000102</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>400 MG;QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13964333</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>100</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>7D29754</drugbatchnumb>
        <drugdosagetext>15 MG/D PO FROM 13SEP07-17SEP07, 30 MG/D PO FROM 18SEP07</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSIONAL DISORDER, PERSECUTORY TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>G30948</drugbatchnumb>
        <drugdosagetext>30 MG PO FROM 14SEP07-18SEP07 AND 35 MG/DAY PO SINCE 19SEP07</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERAZINE</medicinalproduct>
        <drugbatchnumb>062312</drugbatchnumb>
        <drugdosagetext>150 MG PO FROM 23AUG07-19SEP07.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSIONAL DISORDER, PERSECUTORY TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>7C6089</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13965629</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027607</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027432</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>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 3/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEPSAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANATALVIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019356</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>6 MG; QD; PO, 2 MG; ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>6 MG; QD; PO, 2 MG; ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIFLASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KESTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SP008888</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECURRENT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENICA-R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-07P-127-0420509-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE107709AUG04</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO/PREMPHASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00884407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP007552</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>320 MG;</drugdosagetext>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17711</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELITEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506245-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163030ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>70412</drugauthorizationnumb>
        <drugdosagetext>120 MG, 40 MG</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>70412</drugauthorizationnumb>
        <drugdosagetext>120 MG, 40 MG</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010665</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75817</drugauthorizationnumb>
        <drugdosagetext>500 MG; TWICE A DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE (TIGECYCLINE)</medicinalproduct>
        <drugdosagetext>50 MG; TWICE A DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOGUNGIN ACETATE (CASPOFUNGIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANTIDINE (RANITIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>505 MG D1 OF EACH CYCLE 033</drugdosagetext>
        <drugindication>METASTATIC CARCINOMA OF THE BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071007293</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYPTOSPORIDIOSIS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROMOMICINA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CRYPTOSPORIDIOSIS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007982</companynumb>
    <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>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>1X 75UG/HR PLUS 1X 50UG/HR PATCHES APPLIED TOGETHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071008173</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOSEC</medicinalproduct>
        <drugauthorizationnumb>17694</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRONE+ISOMETHEPTENE+CAFFEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1390MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1390MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>139MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>139MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>348MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070800282</companynumb>
    <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>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugbatchnumb>NO LOT NUMBER</drugbatchnumb>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008191</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>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>13,000 MG OR MORE</drugdosagetext>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006303</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061103121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLIM FAST DIET PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060205618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20071100647</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL WEDGE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugauthorizationnumb>020920</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070702843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007453</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007529</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006421</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3-4 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>ADDITIONAL 2 YEARS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006574</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006766</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 2 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070704342</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>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-JNJFOC-20071006759</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007139</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH CALORIE INFUSION</medicinalproduct>
        <drugindication>MALNUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>PHOSPHOSODA FLAVOR NOT SPECIFIED</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE102409AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00639207</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>107.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5MG FOUR TIMES DAILY; AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1 TAB EVERY 8 HOURS, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/12.5 MG; 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50MG; 2 TABLETS THREE TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006375</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>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006651</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>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugdosagetext>DOSE: 3 PAC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006757</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071006854</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20071006682</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>PNEUMOCYSTIS JIROVECI INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>^AFTER FORM CHANGING UP TO 80 MG^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>70075014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50,000 UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007049</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6 MP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007616</companynumb>
    <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>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070705315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071004538</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>6 DF TWICE DAILY (2 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADEINE</medicinalproduct>
        <drugdosagetext>6 DF TWICE DAILY (2 IN 1 D)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFFIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20071006673</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007288</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG AS DIRECTED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>505 D1 OF EACH CYCLE 033</drugdosagetext>
        <drugindication>METASTATIC CARCINOMA OF THE BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINAZAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5MG PRN INHALE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>50MCG OTHER OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>4 MG PRN IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB:</medicinalproduct>
        <drugdosagetext>100MG PO BID TOTAL DOSAGE 5600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0015</drugbatchnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0015</drugbatchnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0015</drugbatchnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</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>ZOLEDRONIC ACID</medicinalproduct>
        <drugbatchnumb>S0028</drugbatchnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>15.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>136.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>48 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>1950 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>150 MCG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8000 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>104 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-L-ASPARAGINASE (K-H)</medicinalproduct>
        <drugdosagetext>3500 UNIT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext> 8 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01780_2007</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>(DF ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>(100 MG DF ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>22750 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>330 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>220 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP017797</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>170 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROMORPH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>17472 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (RHUMAB VEGF)</medicinalproduct>
        <drugdosagetext>1571 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>3120 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>254 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006-05-1909</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>HAEMORRHAGIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>175 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2007-0013965</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROHEPARUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEIN SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM GLYCYRRHIZATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION XL 300MG TEVA</medicinalproduct>
        <drugdosagetext>300MG 1X OROPHARINGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01651</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugauthorizationnumb>21881</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOSPHOSODA FLAVOR NOT SPECIFIED</medicinalproduct>
        <drugdosagetext>X1;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0710S-0425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>40 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11955</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>30 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE289321JUL04</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE324922JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008002</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPLY SLEEP</medicinalproduct>
        <drugbatchnumb>PJM125</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11956</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>30 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12238</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>50 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PURDUE-GBR_2007_0003414</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>2X75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>522 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>96 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAPILLARY THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25MG 1QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-200716271GDS</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIRO 100 MG</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM 4 MG 20 TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX 200 MG 30 TABLETS</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINA NOVOMIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINA NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIKET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268723</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP04135</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHONAL</medicinalproduct>
        <drugdosagetext>10 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050121</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-GILEAD-2007-0014058</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-GILEAD-2007-0012659</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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071007053</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>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE264806SEP05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-CAN_2007_0000395</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugauthorizationnumb>021044</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1650 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1140 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>4480 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>12632 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(RHUMAB VEGF)</medicinalproduct>
        <drugdosagetext>1130 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>2256 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>479 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1380 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>74 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB(MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>690 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717516US</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0061C-B</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                            /00142201/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713298FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERONEM                            /01250501/</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSFOMYCINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>ROUTE: NASOGASTRIC</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200719216GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200712652DE</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003539</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>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULLOUS LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugauthorizationnumb>21730</drugauthorizationnumb>
        <drugdosagetext>PRN; INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO-BISMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>017901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL; 80 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL; 80 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI013932</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>019672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI014233</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>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYDOCALM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701321</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugauthorizationnumb>21654</drugauthorizationnumb>
        <drugdosagetext>1 GM; PO;  DISC. NOS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017672</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US002791</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>75.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019934</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB (NATALIZUMAB)</medicinalproduct>
        <drugbatchnumb>P68018</drugbatchnumb>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
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      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
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        <drugenddate>20061116</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT          (SYMBICORT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5506357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>V06PG9762</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>V06PG9762</drugbatchnumb>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>351460</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>351460</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>FRANCE</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>HYPOTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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  <safetyreport>
    <safetyreportid>5506359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071005021</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>2 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249320</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
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        <drugstartdate>20061001</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-05P-144-0299357-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL RUPTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
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        <drugstartdate>20040708</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
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        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2-3 TABS</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>1-2 TABS</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>1-2 TABS</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HYDROPHILIC MUCILLOID</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPSAICIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOTRACIN</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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    <receiptdate>20071024</receiptdate>
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    <companynumb>JP-ROCHE-528127</companynumb>
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      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
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      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ENDOCRINE OPHTHALMOPATHY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20071101</receivedate>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
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      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
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        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20070827</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugdosagetext>10.05 MG QD INTRAVENOUS DRIP</drugdosagetext>
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        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20070903</drugstartdate>
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        <drugenddate>20070907</drugenddate>
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  <safetyreport>
    <safetyreportid>5506364-X</safetyreportid>
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    <receivedate>20071101</receivedate>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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    <safetyreportid>5506365-1</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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      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>METASTASES TO ADRENALS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
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      <drug>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, BID, ORAL; 250 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, BID, ORAL; 250 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, UID/QD, ORAL;  5 MG, UID, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, UID/QD, ORAL;  5 MG, UID, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (BIOTIN, ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE POLYVALENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002097</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACUGEN</medicinalproduct>
        <drugauthorizationnumb>21756</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, Q6W, INTRA-VITREAL</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007795</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPERICIAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20071004094</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRAL OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506371-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071005465</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERITONSILLAR ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERITONSILLAR ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONSILLAR ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN S</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071100839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070604997</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLASHBACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>WITH A LIMIT OF THREE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLU SHOT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFLUENZA IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2X 250MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002553</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US250105</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-AMGEN-US250343</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</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>ENBREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004858</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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, /D, ORAL; 1.5 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, /D, ORAL; 1.5 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D ORODISPERSABLE CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE (PREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>49.8957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>500MG  TWICE A DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004843</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>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, /D, ORAL; 2 MG, /D, ORAL; 3 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, /D, ORAL; 2 MG, /D, ORAL; 3 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, /D, ORAL; 2 MG, /D, ORAL; 3 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugbatchnumb>GH1031A</drugbatchnumb>
        <drugdosagetext>INHAL</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070403352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071007066</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007550</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070704172</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKINANE LP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006300</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20070904645</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <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>3 DOSES OF 5MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20071008066</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>21999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007937</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugauthorizationnumb>020897</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200716311GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200716018GDS</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>COLITIS COLLAGENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-US250342</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>50/12.5MG 1 TIME PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200716403GDS</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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG  QDAY  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-200716384GDS</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004621</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>LUPUS NEPHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4MG  TWICE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002447</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG BID  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG  3 X''S A DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007315</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>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>1 TAB QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-200716412GDS</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE254520JUL04</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>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00890807</companynumb>
    <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 METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625/2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>98.4306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOKONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA VERSICOLOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004102</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA STAGE III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.1%, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADERM (DEXAMETHASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPSYM (FLUOCINONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUATIM (NADIFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID EXTERNAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>IV   (1 CYCLE EVERY 21 DAYS X 7)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG  QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB 10MG/KG GENENTECH</medicinalproduct>
        <drugbatchnumb>N64836</drugbatchnumb>
        <drugdosagetext>578MG  Q2WKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021209</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>18741</drugauthorizationnumb>
        <drugdosagetext> ;TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>86.1834</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugdosagetext>150MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>102.5129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-08-1932</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTYMPANUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURED BASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUDINE (VIRAMUDINE)</medicinalproduct>
        <drugdosagetext>600 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM (CITALOPRAM)</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>56 MG   D 1 Q 28 D   IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>56 MG  D1,8,15 Q 28 D  IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOCLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>59648</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGRAINE CAPLET/PERRIGO</medicinalproduct>
        <drugauthorizationnumb>75794</drugauthorizationnumb>
        <drugdosagetext>2 CAPSULES/ONCE/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>2 CAPSULES/ONCE/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>148988</drugbatchnumb>
        <drugdosagetext>1 TAB  TWICE DAILY X 10DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1.3 MG/M2  Q 3 WEEKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG  ONE DAILY X 3 D   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG  ONE DAILY X 3 D   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TIBIA FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687796A</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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691141A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LICORICE ROOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691370A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COITAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7D11A</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691382A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC HEADACHE POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691392A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493422A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493786A</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</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>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDRENS PANADOL SUSPENSION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>102884</drugbatchnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>ONE 1 MG TABLET  2 TIWCE PER DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20070305165</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN BRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE (DECITABINE) LYOPHILIZED POWDER</medicinalproduct>
        <drugbatchnumb>04L31LA</drugbatchnumb>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>225 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN TAZOBACTAM (PIP/TAZO) UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN (AMIKACIN) UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (TIENAM) UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NETILMICIN (NETILMICIN) UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFEROXAMINE (DEFEROXAMINE) UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.2449</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100MG  2X DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>44.9061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCTAGAM</medicinalproduct>
        <drugbatchnumb>A733D8431</drugbatchnumb>
        <drugdosagetext>20 GM  DAILY  IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCTAGAM</medicinalproduct>
        <drugbatchnumb>A726A8431</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>185 MG -100 MG/M2-  ONCE   INTRAPERITO</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>3570 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-200716209GDS</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PUNCTURE SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 40 MG  UNIT DOSE: 40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 75 MG  UNIT DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALS</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROSALURETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDYL</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-511233</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>79.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>155 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>65 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007P1000256</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN (BUSULFAN)</medicinalproduct>
        <drugauthorizationnumb>20954</drugauthorizationnumb>
        <drugdosagetext>; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5MG DAILY X 3 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE NONUNION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5MG DAILY X 3 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5MG DAILY X 3 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TIBIA FRACTURE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUCROSE</medicinalproduct>
        <drugdosagetext>1 GRAM INFUSED OVER 3 HRS IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-21880-07100412</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0014C-C</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2 IN 1 D, ORAL; 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>5Q-SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0014C-C</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2 IN 1 D, ORAL; 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>5Q-SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427916</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE (PANCRELIPASE) (CAPSULES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINOLONE (QUINOLONE NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABELTALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>009-C5013-07051550</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY FOR 21 DAYS, ORAL; 15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY FOR 21 DAYS, ORAL; 15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, D1-4, 9-12, 17-20 EACH 28 DAYS CYCLE,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>800MG/160MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>800MG/160MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E3810-01340-SPO-PR</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>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6 MG/KG,</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6 MG/KG,</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODOZ (BISELECT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056C-B</drugbatchnumb>
        <drugdosagetext>5MG EVERY OTHER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedate>20071101</receivedate>
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    <receiptdate>20071024</receiptdate>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20040917</drugstartdate>
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        <drugenddate>20070302</drugenddate>
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      <drug>
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        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
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    <safetyreportid>5506451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
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    <receiptdate>20071024</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
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    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <drug>
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        <drugdosagetext>IM</drugdosagetext>
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    <receivedate>20071101</receivedate>
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    <receiptdate>20071023</receiptdate>
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    <patient>
      <patientonsetage>61</patientonsetage>
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    <patient>
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    <transmissiondateformat>102</transmissiondateformat>
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    <safetyreportid>5506458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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        <drugstartdate>20061001</drugstartdate>
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        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORECAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506478-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
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    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>AUSTRALIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>25422</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>320/9 UG BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
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        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
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        <drugenddate>20070630</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICOR</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMIDE</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALOHEXAL</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>STARTED }6 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5506479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2007AC02036</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
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  <safetyreport>
    <safetyreportid>5506480-2</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE05466</companynumb>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>16199</patientonsetage>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20051104</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
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        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
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        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
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        <drugenddate>20070930</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
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        <drugstartdate>20070415</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20060615</drugstartdate>
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        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>5506481-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20050101</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506482-6</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>
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        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
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      <drug>
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        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>5506483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20071101</receivedate>
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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>44</patientonsetage>
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        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
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    <safetyreportid>5506484-X</safetyreportid>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018489</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>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0684005B</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL DOUCHE (ALCOHOL)</medicinalproduct>
        <drugdosagetext>SINGLE DOSE/ TRANSPLACENTA</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018565</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>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>20 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32008</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333464</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
        <drugdosagetext>5.5 GRAMS DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>OSTEOARTHRITIS</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS (CALCIUM CHANNEL BLOCKERS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00147</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</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>20011124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>1185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>1135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018430</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>COLON CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01090</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA03905</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>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA03908</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>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060816</drugenddate>
        <drugtreatmentduration>1964</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0704USA01592</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0710MYS00022</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA00686</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>GOUTY ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA04494</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018366</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>117.028</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32018</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018302</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 UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007TR03537</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTRIVIN</medicinalproduct>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019153</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019049</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018869</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32001</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0607297A</companynumb>
    <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>DISSOCIATIVE IDENTITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>24MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>DYSKINESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0640667A</companynumb>
    <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>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</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>20000808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0646230A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0668696A</companynumb>
    <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>POSTOPERATIVE THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0668712B</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>41.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>4MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</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>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0684737A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>7ZP9781</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0684781A</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>61.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>3MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0686491A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689870A</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>118.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44MCG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690171A</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>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690779A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690794A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691099A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691287A</companynumb>
    <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>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691307A</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TRIAL MEDICATION</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691309A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691323A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST 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>20061213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>90MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691514A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>150MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE-35</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0458345A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>4PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AIROMIR AUTOHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONKYL</medicinalproduct>
        <drugdosagetext>200MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMUDAL</medicinalproduct>
        <drugdosagetext>10ML FOUR TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX</medicinalproduct>
        <drugdosagetext>500MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCULAC</medicinalproduct>
        <drugdosagetext>4DROP AT NIGHT</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA TOCOPHEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVENING PRIMROSE OIL</medicinalproduct>
        <drugdosagetext>2UD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WILD YAM</medicinalproduct>
        <drugdosagetext>2UD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDOBACTERIUM LONGUM</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRACT OF ENTEROCOCCUS FAECALIS</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEN</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINK</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA WITH VITAMIN C</medicinalproduct>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURAL MEDICATION</medicinalproduct>
        <drugdosagetext>5DROP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC ANTIBACTERIAL MEDICATION</medicinalproduct>
        <drugdosagetext>5DROP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>1TSP AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURAL MEDICATION</medicinalproduct>
        <drugdosagetext>2CUP PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC ANTIBACTERIAL MEDICATION</medicinalproduct>
        <drugdosagetext>5DROP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC ANTIBACTERIAL MEDICATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC ANTIBACTERIAL MEDICATION</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARANTH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0478083A</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>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0482698A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-VIRAL MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0483341A</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0484925A</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</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>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17)</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007TR03538</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTRIVIN</medicinalproduct>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485348A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIOLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIOLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486215A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487479A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</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>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMOFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488043A</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLILOQUY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070324</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488101A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPYRESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRADIOMYCIN SULPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>375MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488414A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FP</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488452A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>30MG MONTHLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490114A</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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490158A</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2650MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490346A</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>37.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</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>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>1320MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492598A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugauthorizationnumb>20833</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492742A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200700674</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>81.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS; 0.75 MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>600 MG, SINGLE LOADING DOSE,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492743A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>200MCG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>200MCG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492750A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>450MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492922A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492982A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>21003</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIONINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493383A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</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>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493384A</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>72MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>280MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493386A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELEVATED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493390A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493475A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493504A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>4000MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>40ML PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>250MCG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493506A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE HCL</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>9MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493622A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugindication>BASAL GANGLION DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493699A</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>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINNAT</medicinalproduct>
        <drugauthorizationnumb>50605</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERRA-CORTRIL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493768A</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506556-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493774A</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070505</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KESTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070505</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493793A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC DECOMPENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493795A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>050754</drugauthorizationnumb>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493824A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRYPTASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493846A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493863A</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI ANTALVIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054095A</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFIRIL LONG</medicinalproduct>
        <drugdosagetext>300MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029932</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0710-SPO-VANT-0184</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTAS</medicinalproduct>
        <drugauthorizationnumb>21732</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 Y, SUB Q. IMPLANT</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL SUPPLEMENT (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007TR03539</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTRIVIN</medicinalproduct>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN 650MG/ PERRIGO COMPANY</medicinalproduct>
        <drugauthorizationnumb>75077</drugauthorizationnumb>
        <drugdosagetext>ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007TR03540</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTRIVIN</medicinalproduct>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>74937</drugauthorizationnumb>
        <drugdosagetext>ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>203</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>74937</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>58190</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN, ASPIRIN AND CAFFEINE</medicinalproduct>
        <drugauthorizationnumb>75794</drugauthorizationnumb>
        <drugdosagetext>1-2 TABLETS/EVERY 4 HOURS/ORAL;  X2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>210</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>74937</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60421</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING DELIBERATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>105 G/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APOPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANALGESIC ASTHMA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
        <drugdosagetext>100MG/ ONCE/ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
        <drugdosagetext>100 MG/ ONCE/ ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VANISHING BILE DUCT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL PAPILLARY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>75367</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>2 TABS/TID/DURING THE PRECEDING 3 WEEKS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020529</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDODEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>77114</drugauthorizationnumb>
        <drugdosagetext>600MG/TID/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15084</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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5506586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20050127</drugstartdate>
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        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>870</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971020</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15083</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE02326</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>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTANOL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRONAJOD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006FR07535</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060510</drugenddate>
        <drugtreatmentduration>1681</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR03420</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD COMPRESS THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUGERON</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LABYRINTHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LABYRINTHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01250</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERAL NUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP15383</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>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATENT AUTOIMMUNE DIABETES IN ADULTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAA489 OR VAL489 OR AMLO. VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>PLACEBO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAA489 OR VAL489 OR AMLO. VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO KOWA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029943</companynumb>
    <primarysource></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>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506596-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11254</companynumb>
    <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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>20802</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC COLD + ALLERGY ORANG (NCH) (CHLORPHENIRAMINE MALEATE, PSEUDO</medicinalproduct>
        <drugbatchnumb>10036391</drugbatchnumb>
        <drugdosagetext>ONCE/SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC CHEST CONGESTION CITRUS 4 OZ (NCH) (PSEUDOEPHEDRINE, GUAIFEN</medicinalproduct>
        <drugdosagetext>1 TSP, EVERY 4 TO 5 HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>STARTING DOSE GIVEN ON DAYS 2 TO 15 AND 23 TO 36</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>STARTING DOSE - GIVEN OVER 90 MINUTES ON DAYS 1, 8, 22 AND 29</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETIC</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-527324</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-526269</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-515381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>82824</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>82824</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: VIAL.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>52211</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>TRADE NAME: CPAP.</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>NEBULIZER.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200720050GDDC</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>D238</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: ACCORDING TO GLYCEMIA</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIFAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712048JP</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>51.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 6 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>DOSE: 8UNITS[4-0-4-0]</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN                             /00082702/</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200716994US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-AVENTIS-200719910GDDC</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719904GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREX                               /00024401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-527588</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>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINE B6</medicinalproduct>
        <drugdosagetext>DOSAGE: 1 DOSE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B1</medicinalproduct>
        <drugdosagetext>DOSAGE: 1 DOSE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI ANTALVIC</medicinalproduct>
        <drugdosagetext>DOSAGE: 6 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-528438</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED: ORAL FORMULATION (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-505167</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugdosagetext>DOSE 6 DOSES EVERYDAY</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-528261</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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11199</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>88.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU VAPOR PATCH (NCH)(EUCALYPTUS OIL, CAMPHOR, MENTHOL) PATCH</medicinalproduct>
        <drugbatchnumb>10036833</drugbatchnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0706USA04847</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>104.7809</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT 100 MG</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 300 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT 100 MG</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 300 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.9 MG/DAILY/IV; 0.7 MG/M[2]/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.9 MG/DAILY/IV; 0.7 MG/M[2]/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CC2007-045</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>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugbatchnumb>AS068A7</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007P1000683</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>40</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL GANGLION DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFEX</medicinalproduct>
        <drugauthorizationnumb>20954</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>0.4 MG/KG;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC PNEUMONIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFIBROTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRILAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTOMENADIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-461433</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BANAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>STARTING DOSE - GIVEN DAYS 2 TO 15 AND 23 TO 36</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>GIVEN OVER 90 MINUTES ON DAYS 1, 8, 22 AND 29</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETIC</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-425382</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>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
        <drugauthorizationnumb>019661</drugauthorizationnumb>
        <drugdosagetext>FORM = VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
        <drugauthorizationnumb>019661</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>RESTARTED ON 17 SEPTEMBER 2005 AT THE SAME DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>RESTARTED ON 26 AUGUST 2005 AT THE SAME DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>ROUTE = BOTH EYES, AT NIGHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-480173</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>TWICE DAILY STARTING ON DAY 1, TARGETING A WHOLE BLOOD TROUGH LEVEL OF 300-400 NG/ML,</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>METHOTREXATE 15 MG/M2 INTRAVENOUS ON DAY 1 AND 10 MG/M2 INTRAVENOUS ON DAYS DAY 3 AND DAY 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>METHYLPREDNISOLONE 0.4 MG/KG/ DOSE TWICE DAILY FROM DAY -4 TO DAY 28 WITH SUBSEQUENT DOSAGE REDUCTI+</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>METHYLPREDNISOLONE DOSAGE WAS INCREASED TO 2 MG/KG INTRAVENOUS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>5 MG/KG/DAY S.C. FROM DAY 5 UNTIL NEUTROPHIL COUNTS WERE 41.0_109/L FOR AT LEAST TWO CONSECUTIVE DA+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>FLUDARABINE 30 MG/M2/DAY INTRAVENOUS FROM DAY 10 TO DAY 5 (TOTAL DOSE 180 MG/M2),</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>CYCLOPHOSPHAMIDE 60 MG/KG/DAY INTRAVENOUS ON DAYS 6 AND 5 (TOTAL DOSE 120 MG/KG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>TRIMETHOPRIM-SULFAMETHOXAZOLE 75 MG TRIMETHOPRIM/M2 TWICE DAILY ORALLY STARTING 1 DAY BEFORE CONDIT+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS IMMUNOGLOBULINS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATGAM</medicinalproduct>
        <drugdosagetext>EQUINE ANTITHYMOCYTE GLOBULIN 40 MG/KG/DAY FROM DAY 4 TO 1 (TOTAL DOSE 160 MG/KG).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>FROM DAY -3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>FROM DAY -3 TO 20</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-506348</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>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-497436</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-506270</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-508258</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>88.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>76520 / 80284</drugbatchnumb>
        <drugdosagetext>ADMINISTERED WEEKLY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>78914</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>78914</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>BLINDED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED RO 4588161 (HCV POLYMERASE INH)</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>BLINDED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOY PROTEIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACID INJ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-515527</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>CENTRAL PONTINE MYELINOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CRYOGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CRYOGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B CO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-522994</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>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REDUCED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REDUCED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-511915</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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugdosagetext>AS OF 22 JUNE 2007, GIVEN AS NEEDED. AS OF AN UNSPECIFIED DATE, GIVEN AT A TOTAL DAILY DOSE OF 22 U+</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>AS OF 22 JUNE 2007, GIVEN AT A TOTAL DAILY DOSE OF 80 MG. AS OF 04 JULY 2007, GIVEN AT A TOTAL DAIL+</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1/VITAMIN B6</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS VIT B1 B6.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS 160.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TYCO HEALTHCARE/MALLINCKRODT-T200701312</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>075983</drugauthorizationnumb>
        <drugdosagetext>50 MG, SINGLE</drugdosagetext>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>15 MG, SINGLE</drugdosagetext>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-524176</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORCEVAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-523004</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VX-950</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ADVAIR DICUS (SERETIDE MITE).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-523021</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 4 FEBRUARY 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>THERAPY PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 16 APRIL 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>THERAPY PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 16 APRIL 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>REPORTED AS METHYLPREDNISONE.  TEMPORARILY PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - FOLIC ACID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - FERRUM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - VITAMIN B12</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS CALCIUM BICARBONATE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS 300000 UI.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-525634</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOGAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-525750</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028511</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK, SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#5#2007-00195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE (DOSE UNKNOWN), PATCH (SILICONE) (ROTIGOTINE)</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>12 MG/24H (12 M/24H 1 IN 1 DAY(S))</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE (SELEGILINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA, LEVODOPA (CARBIDOPA, LEVODOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (MORNIFLUMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIFENACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASAGILINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRINZOLAMIDE (BRINZOLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROS (LATANOPROST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029973</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>560 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01657</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSMOPREP</medicinalproduct>
        <drugauthorizationnumb>21892</drugauthorizationnumb>
        <drugdosagetext>105 GM (SINGLE ADMINISTRATION), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL PREPARATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0710S-0424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>SINGLE DOSE;</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0710S-0427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>, SINGLE DOSE</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GADOPENTETATE DIMEGLUMINE (MAGNEVIST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029938</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-1164463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVANAC</medicinalproduct>
        <drugauthorizationnumb>21862</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-414259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK RELATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438836</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>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19841101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVIGILANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE BODY IN JOINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MERYCISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELECTIVE IGA IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugbatchnumb>B1023-50</drugbatchnumb>
        <drugauthorizationnumb>19591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAQUINE</medicinalproduct>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-421329</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>82.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>81713046</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>81713094</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>FOR MAINTENANCE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>FOR MAINTENANCE.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>FOR MAINTENANCE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-507531</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20MG BID FOR ONE MONTH, THEN 20MG TID FOR ONE MONTH, THEN 40MG BID(2 IN AM AND 2 IN PM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE DOSAGE NOT PROVIDED FOR JULY 2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTRET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-457756</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>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>KH06589</drugbatchnumb>
        <drugdosagetext>FORM REPORTED AS INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>5H06351</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>REPORTED AS DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-526986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugindication>BLADDER SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; X1; TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>50 UG/HR; X1; TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE251720JUL04</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>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-455252</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>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>71905</drugbatchnumb>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS DAILY X 14 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>M72798</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM REPORTED AS VIAL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM REPORTED AS VIAL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVACOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10643</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PANCREATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10989</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFIBRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN 850MG TABLETS</medicinalproduct>
        <drugdosagetext>850 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-10974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007RR-10730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070469</drugauthorizationnumb>
        <drugdosagetext>400 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>070469</drugauthorizationnumb>
        <drugindication>MALAISE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/PSEUDOEPHEDRINE HCI/DEXTROMETHORPHAN HBR</medicinalproduct>
        <drugindication>ASTHENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/PSEUDOEPHEDRINE HCI/DEXTROMETHORPHAN HBR</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOBENZAMIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
        <drugdosagetext>0.125 MG, PRN</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1008358</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>1P4867</drugbatchnumb>
        <drugauthorizationnumb>76187</drugauthorizationnumb>
        <drugdosagetext>50 UG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE VAGINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERON /00103101/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#9#2007-00262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugauthorizationnumb>75155</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>25MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>25MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>25MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>10MCG,ASNEC; INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANGRELOR VS PLACEBO (CODE NOT BROKEN) INJECTION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-09193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027309</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>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW09272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>445</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>118.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STELAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071004400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX DM</medicinalproduct>
        <drugbatchnumb>PL00002147</drugbatchnumb>
        <drugauthorizationnumb>21620</drugauthorizationnumb>
        <drugdosagetext>1TABL, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071004429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>17756</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugdosagetext>0.5TSP, Q12HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021385</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>7-CO-8002</drugbatchnumb>
        <drugdosagetext>50 MCG; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>6-CO-4003</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020049</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>92.5338</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>430 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPI200700732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugauthorizationnumb>21908</drugauthorizationnumb>
        <drugdosagetext>24 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN 650MG/ PERRIGO COMPANY</medicinalproduct>
        <drugauthorizationnumb>75077</drugauthorizationnumb>
        <drugdosagetext>ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-G00526507</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE341827SEP07</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2003P0338; 2006P1387</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>764</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2003P0338; 2006P1387</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>563</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2003P0338; 2006P1387</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2003P0338; 2006P1387</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE# 07-021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>75423</drugauthorizationnumb>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-007480-07</companynumb>
    <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>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VN-BAXTER-2007BH007433</companynumb>
    <primarysource>
      <reportercountry>VIET NAM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>S07F25015</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13651542</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>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1 PILL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1 PILL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1 PILL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPSAICIN</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1 PILL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM=1 PILL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>50 G</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13963046</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BRISTOL-MYERS SQUIBB COMPANY-13959986</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY GAS EXCHANGE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE(400MG/M2,1 IN 1 ONCE)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13831490</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HIV RNA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugdosagetext>STOPPED ON 29NOV2005 AND RESTARTED ON 25MAY2006.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02187</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06515</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12215</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE SOLUTION 4%</medicinalproduct>
        <drugauthorizationnumb>10417</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW22980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29854</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugdosagetext>ONE SPRAY EACH NOSTRIL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>100-150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13967955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13741442</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXART</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13965751</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050928</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13967799</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>57</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV OVER 2 HRS ON WEEK 1, CYCLE 1 ONLY, 250 MG/M2 IV OVER 2 HRS ON WEEK 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>FIRST COURSE ON 12-SEP-2007, AUC 6 IV OVER 30 MIN Q 21 DAYS STARTING WEEK 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>200 MG/M2 IV OVER 3 HRS Q 21 DAYS STARTNG WEEK 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG IV OVER 90-30 MIN, Q 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13966049</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13955125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>13-JAN-2007- 400 MG/M2 ON DAY ONE, WEEK 1 ONLY, THEN 250 MG/M2 OVER 60 MINUTES WEEKLY FOR 6 WEEKS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>FIRST COURSE WAS ON 13-JAN-2007.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugdosagetext>500 MG/M2 ON DAY 1X4 CYCLES. FIRST COURSE 13-JAN-2007.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSAGE FORM EQUALS GY.</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13883848</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugauthorizationnumb>21336</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugauthorizationnumb>021336</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHOBID</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 0.9 (NO UNITS)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2007BH008505</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERITONITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-07P-127-0420508-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0419186-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</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>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506702-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006413</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>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <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>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506703-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A302400</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK, 4/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506704-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VENTRICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A309432</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506705-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005958</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006986</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506707-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006663</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB TRAUMATIC AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</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>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005945</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200710006812</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>8 IU, 4/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>24 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>12 U, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006753</companynumb>
    <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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A349467</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A349467</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006440</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006709</companynumb>
    <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 CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006677</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <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>5506718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710006116</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710006617</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311536</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC /01263201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVENTYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506720-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006668</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>30 U, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506721-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.413</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>9RY67M</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710007359</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 GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>110 U, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>100 U, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE + VITAMIN D</medicinalproduct>
        <drugdosagetext>500 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</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>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>200 UG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710006488</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFOL 200MG/ PERRIGO COMPANY</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>51 MG/KG</drugdosagetext>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006877</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>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006703</companynumb>
    <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 CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US239886</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249476</companynumb>
    <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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095192</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095192</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU241542</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>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-US247391</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506733-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506734-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US246048</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US244110</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US250332</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK249997</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60623</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-AMGEN-US250646</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC RESINATE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249545</companynumb>
    <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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX247765</companynumb>
    <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 STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN/TID/ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER ADENOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506747-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60679</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>72096</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERFENADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A254270</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIS NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugdosagetext>40 U, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugdosagetext>5 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG/KG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, AS NEEDED BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002565</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>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1500 MG, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A328839</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000641</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A322537</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007069</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A297166</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-US_021088942</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506756-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004798</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES HARD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ELI_LILLY_AND_COMPANY-AR200707000856</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT200710007499</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>28 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>14 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007107</companynumb>
    <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>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A271295</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506761-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATAPLEXY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>4.5 GM 2.25 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506762-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04736</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>70857</drugauthorizationnumb>
        <drugdosagetext>50 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2007PK02097</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18769</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506764-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163135USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>(20 MG), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>121861USA</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>
      <patientweight>127.0072</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugbatchnumb>123424</drugbatchnumb>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MG/ML (20 MG/ML, ONCE A DAY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VTAMIN B COMPEX</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>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163325USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>(20 MG), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506767-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EN000262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>21610</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003043</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>73.0291</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugauthorizationnumb>21730</drugauthorizationnumb>
        <drugdosagetext>PRN; INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO-BISMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCOF XP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHAZYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003572</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>1.25 MG/3ML;Q4H; INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX 23</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0645525A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROGEN PEROXIDE SOLUTION (FORMULATION UNKNOWN) (HYDROGEN PEROXIDE SO</medicinalproduct>
        <drugbatchnumb>6K1001</drugbatchnumb>
        <drugdosagetext>DENTAL</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H00994307</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0422416-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333935</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>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>562375</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>2 CAPSULES TWICE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEDIACARE DECONGESTANT (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007089873</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007079902</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACIN S</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007331620</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>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL CREAM EXTRA STRENGTH (DIPHENHYDRAMINE, ZINC ACETATE)</medicinalproduct>
        <drugbatchnumb>559D61</drugbatchnumb>
        <drugdosagetext>3 X 1 DAY,TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS CONTACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL CREAM EXTRA STRENGTH (DIPHENHYDRAMINE, ZINC ACETATE)</medicinalproduct>
        <drugbatchnumb>459N6L</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS CONTACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506780-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333728</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>EVERY 6 HOURS (400MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN WARM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/DEXTROMETHORPHAN/PSEUDOEPHEDRINE (PARACETAMOL, PSEUDOEPH</medicinalproduct>
        <drugdosagetext>ONE DOSE UNSPECIFIED</drugdosagetext>
        <drugindication>ASTHENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAOCULAR MUSCLE PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090170</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPANUTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.636</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>PROSTATECTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11256</companynumb>
    <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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>4 WAY NASAL DECONGESTANT MOISTURIZING RELIEF (NCH) (XYLOMETAZOLINE HYD</medicinalproduct>
        <drugdosagetext>ONCE/SINGLE, NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11269</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>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11230</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>68.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506788-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2007091295</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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTRIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091101</companynumb>
    <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>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090955</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugauthorizationnumb>18045</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:9MG</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018682</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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506794-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020541</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>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090857</companynumb>
    <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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP15383</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>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATENT AUTOIMMUNE DIABETES IN ADULTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAA489 OR VAL489 OR AMLO. VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>PLACEBO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAA489 OR VAL489 OR AMLO. VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO KOWA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007090717</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15211</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>870</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090587</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>165</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>DAILY DOSE:80MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019822</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019334</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019222</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>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32018</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021590</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090166</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>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090127</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROSTOMY TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPANUTIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090161</companynumb>
    <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506810-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040411</companynumb>
    <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG/1XWK VARIED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-041207</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>71529 A</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>.1 MMOL, PER KG BODY WEIGH</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-040958</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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCOPE 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>3 ML/SEC, BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007090112</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8746AA</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8746AA</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CONCOMITANT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020848</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-040868</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK MIU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506818-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-027301</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-036710</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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9497A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20070602286</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20071007181</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR EMBRYONAL CARCINOMA STAGE III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>INFUSIONS AT WEEK 0, 2, 6, AND THEREFORE EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOLITIS HAEMORRHAGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070507209</companynumb>
    <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007090075</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERENTEROL</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMID</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>BLOOD UREA INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020710</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006710</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071001222</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>6R17KA709</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>6R17KA709</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMRANETTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070805739</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPERFUSION ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022499</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>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-032870</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>1200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070804488</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>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071000543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN DAMAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041035</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>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2006-040042</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>4 MG/KG, DAY-6 TO -5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, DAYS -8 TO -3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090009</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>011757</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:120MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007500</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>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-SHR-NZ-2007-033842</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>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLES 1-4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>25 MG, CYCLES 5 AND 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>500 MG, CYCLES 1-4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG, CYCLE 5 AND 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
        <drugdosagetext>.5 MG/D, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG/D, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>960 MG, 3X/WEEK, MON, WED, FRI</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA                                  /AUS/</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A01200712073</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200700202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <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>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-040641</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-037296</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>30 MG/KG, UNK</drugdosagetext>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>4 MG/KG, UNK</drugdosagetext>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.03 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040624</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>88.435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>41194A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHR-FR-2007-039639</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040423</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022534</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200700206</companynumb>
    <primarysource>
      <qualification>3</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>CLOPIDOGREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200700314</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG (312.5 MG/M2 IV BOLUS FOLLOWED BY 2500 MG (1562.5 MG/M2) INFUSION ON D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>250 MG (156.3 MG/M2) INFUSION ON D1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-SYNTHELABO-A01200712289</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007089967</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089942</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>BLOOD PARATHYROID HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506854-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200712165</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200606533</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG AT 1 P.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG Q6H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2-3 TABLETS Q AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 TABLET EVERY 4 HOURS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090597</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022211</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 ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>DRUG EXPOSURE VIA BREAST MILK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-036665</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-025961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>1093</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>500 OR 250 IU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506863-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071000433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYSTAL URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULITVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRODRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018344</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>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATLIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-040656</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-036888</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>79.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>500 A?G, DAYS 1-14</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090007</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>LUNG ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-031480</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>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>40 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>800 MG, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE052926OCT04</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>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE045808JUL05</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>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706108</companynumb>
    <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706166</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706187</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>95.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCODAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706197</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF SEXUAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090469</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugauthorizationnumb>019268</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>FREQ:TRICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090590</companynumb>
    <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>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090320</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2007090245</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016471</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>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022793</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>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68026</drugbatchnumb>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018739</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE-SODIUM SULFACETAMIDE 0.25% SODIUM PHOSPHATE 10%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM AND VITAMIN D COMBINATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2007090243</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2007090186</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPULSIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090154</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPES VIRUS 6 SEROLOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091297</companynumb>
    <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 ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
        <drugdosagetext>TEXT:0.5 MG/2.5 MG-FREQ:DAILY</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:160MG-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018596</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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018485</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>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020827</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021072</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090830</companynumb>
    <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-35</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090838</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090827</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090791</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020460</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>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019983</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>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-HBS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30783_2007</companynumb>
    <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>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugauthorizationnumb>12093</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2007090746</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090727</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250211</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>99.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG/KG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>125 MG/M2, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021462</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>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugbatchnumb>PB33306</drugbatchnumb>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME). MFR: GENZY</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME). MFR: GENZY</medicinalproduct>
        <drugdosagetext>20 MG;KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2007090677</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091972</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:80MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER R</medicinalproduct>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:30MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091446</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089913</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10488</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021548</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>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007089748</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422443-00</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>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>454039A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>454039A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0415086-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0422267-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422677-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423196-00</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2007089713</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIBAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>40586/40587</drugbatchnumb>
        <drugdosagetext>1140 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>40586/40587</drugbatchnumb>
        <drugdosagetext>1140 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>40586/40587</drugbatchnumb>
        <drugdosagetext>1140 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PLACEBO</medicinalproduct>
        <drugbatchnumb>40586/40587</drugbatchnumb>
        <drugdosagetext>1140 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1860 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>384 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>300 A?G, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089642</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>86.363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-PFIZER INC-2007089473</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERICARDIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>280 MG/M2, 1 IN 2 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>140 MG/M2, 1 IN 2 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE359622JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.71</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089219</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN RD</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007088213</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugauthorizationnumb>021437</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007086347</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087671</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>011111</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007084048</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007081655</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2007081395</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007079541</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>120.13 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-PFIZER INC-2007068218</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>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248310</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</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>20061021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOT SPECIFIED)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID INJECTION NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007065568</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>050162</drugauthorizationnumb>
        <drugindication>DENTAL OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006118351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGRY BONE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL TURBINATE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOMOTOR RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROAMPHETAMINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:180MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>ADENOMA BENIGN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1000I.U.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:325MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATITIS B VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROAMPHETAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</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>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COFFEE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASALCROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMETAZOLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPROPYLHEXEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US236442</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHISTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250408</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074204</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>360.47 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET)</medicinalproduct>
        <drugbatchnumb>156374</drugbatchnumb>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugbatchnumb>18142</drugbatchnumb>
        <drugdosagetext>735 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugbatchnumb>18656</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PF-3512676</medicinalproduct>
        <drugdosagetext>19 MG, DAYS 1, 8 AND 15)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021117</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000911</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01095</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022672</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>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022707</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>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01099</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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  <safetyreport>
    <safetyreportid>5506954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249291</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>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY TREATMENTS NOS</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0371555-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>OSTEOTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>OSTEOTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>OSTEOTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED OPIOIDS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05653-01</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>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0418907-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <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>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOXICAM</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIRACOXIB</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE305525SEP07</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>23624</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05623-01</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05515-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID (OMEPRAZOLE/SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05707-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG, QID</drugdosagetext>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSU-2007-00777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERAL XR (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAM</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1X/DAY:QD, ORAL;1/3 OF A 15 MG CAPSULE, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERAL XR (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAM</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1X/DAY:QD, ORAL;1/3 OF A 15 MG CAPSULE, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04733</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>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugdosagetext>1000 MG, 3X/DAY:TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPITVAR (AZELASATINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROVITE (ASCORHBIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CYANOCOBALAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID /00706001/ (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2007Q01425</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>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1 IN 1 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN /01229101/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ACORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEETS ENEMA (PARAFFIN, LIQUID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07091263</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>URINE HUMAN CHORIONIC GONADOTROPIN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD X21 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07080518</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0154B-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0154B-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07010006</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>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427925</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 - 15MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>427919</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATIL(CISPLATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTON(ROSUVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101387</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100844</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>50 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>75 A?G/HR, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>22 UNIT, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>800 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 A?G, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG, QHS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 UNK, Q1H</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugdosagetext>30 MG, QOD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100594</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>428564</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>X21 DAYS EVERY 28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CVT-070175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>21526</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAYPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA(FEXOFENADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ATOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>75472</drugauthorizationnumb>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>75472</drugauthorizationnumb>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SECONDARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422349-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>88058</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PELVIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PELVIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-UK-03360UK</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>AGGRENOX</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugdosagetext>BLINDED STUDY DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>088587</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23418YA</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <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>OMNIC OCAS ORODISPERSABLE CR</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22719BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22813BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19651BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0613758</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23186BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23203BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23205BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23213BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23215BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-04616BP</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23656BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-03475BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>506583B,4C2219</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K+</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-14004NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23753BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22824BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>NOCTURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>URINARY HESITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22807BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22722BP</companynumb>
    <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23216BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22821BP</companynumb>
    <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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22785BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21565BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>98</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0613750</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5506999-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22778BP</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507000-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22811BP</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>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507001-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22760BP</companynumb>
    <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 RIGIDITY</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>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507002-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23214BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507003-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23206BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <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>5507005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23204BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23187BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22896BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22892BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20678BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070128W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23648BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23646BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-09464BP</companynumb>
    <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>OBSESSIVE-COMPULSIVE DISORDER</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>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugindication>ASTHENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>LARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS BOOSTER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE VAG CREAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL CAP</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAFIORA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDRO RELIEF</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDURA</medicinalproduct>
        <drugindication>PHYTOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINAFORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXHILARIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDESEN</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADHA</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23655BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-10134BP</companynumb>
    <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>OBSESSIVE-COMPULSIVE DISORDER</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>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KWO-6002</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON M20</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL PREPARATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL STIMULANT</medicinalproduct>
        <drugindication>ENERGY INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL STIMULANT</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HDROZYME</medicinalproduct>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HDROZYME</medicinalproduct>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HDROZYME</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAINE PLUS</medicinalproduct>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAINE PLUS</medicinalproduct>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAINE PLUS</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED CAPSULE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITALZYME-SERRA PEPTASE</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITALZYME-SERRA PEPTASE</medicinalproduct>
        <drugindication>POOR PERIPHERAL CIRCULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFORN FORTE DSC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINAZA HERBALLAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALGAN INJECTIONS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06320GD</companynumb>
    <primarysource></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>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17863BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>701930A,7C2201</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22849BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BL-00174BL</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEDICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXSOTEN</medicinalproduct>
        <drugdosagetext>HALF OF 10/25 MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERNATIONAL NORMALISED RATIO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTRAN</medicinalproduct>
        <drugdosagetext>50MG/0,72ML (20 DROPS=0,72ML)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACODINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22708BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20636NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHAGEN (GLYCYRRHIZIC ACID_DL METHIONINE COMBINED DRUG  )</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE (D-CHLORPHENIPRAMINE MALEATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06359GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugdosagetext>MEDIAN DOSE 3 MCG/KG, STARTING DOSE 2 MCG/KG, ADAPTED ON DEMAND TO 5 MCG/KG</drugdosagetext>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06328GD</companynumb>
    <primarysource></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>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507023-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06323GD</companynumb>
    <primarysource></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>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-04616BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</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>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON-N</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN VAGINAL CREAM</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ASA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE/SOY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JARRO-DOPHILUS EPS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON 65</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUIAFINEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugindication>FAT INTOLERANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLISTIN (RED YEAST)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA 4 MAG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROM 400</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGNOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTORPHANOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06414DE</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
        <drugindication>OPTIC NERVE INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPOTALON</medicinalproduct>
        <drugdosagetext>MIXED WITH XYLOCAIN</drugdosagetext>
        <drugindication>EPICONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06262DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHONESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELIOSIS HEPATIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVUM</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN (NON BI-DRUG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-UK-00770UK</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23599AU</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22812BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705425A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22759BP</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</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>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22814BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOSMIA</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>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23716NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22895BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22864BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23654BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22847BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23553BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH ALCOHOL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOHIST</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TISADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22845BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22717BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23627BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-11094BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23458BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>20071014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23679PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23630BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELECTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507045-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23759BP</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</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>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CROUP INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REYE'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19851006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19851006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVAHISTINE ELIXIR (CHLOROFORM, CHLORPHENAMINE MALEATE, MENTHOL, PHENY</medicinalproduct>
        <drugdosagetext>1 TSP TWICE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06415GD</companynumb>
    <primarysource></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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugdosagetext>TIPRANAVIR 1000 MG/RITONAVIR 400 MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507048-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22797BP</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507049-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22886BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507050-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22718BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507051-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06332GD</companynumb>
    <primarysource></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>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
        <drugindication>TOURETTE'S DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06329DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>POST PROCEDURAL STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>HEMIPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>DYSARTHRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507053-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23647BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507054-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19148BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702049A,7C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702049A,7C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19361BP</companynumb>
    <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>URETERAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC DILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507056-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20222BP</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070127W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18959BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702049A,7C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22427BP</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703709B,7C3201</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22455BP</companynumb>
    <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22463BP</companynumb>
    <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>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22561BP</companynumb>
    <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>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>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22562BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22497BP</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>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333640</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYLAMINE SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN W/DEXTROMETHORPHAN (DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZ</medicinalproduct>
        <drugdosagetext>LESS THAN ONE TEASPOON, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, WKS 1 + 4</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>50 MG/M2, WK 1-6</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007332467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING PRE-BRUSH RINSE (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>686D6C</drugbatchnumb>
        <drugdosagetext>3 TEASPOONS ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507067-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007316690</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>
      <patientweight>23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE GLACIER MINT (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>91436L</drugbatchnumb>
        <drugdosagetext>10 ML, 3-4 TIMES WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334040</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>44.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE EYE DROPS</medicinalproduct>
        <drugauthorizationnumb>19407</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN (NCH)(WHEAT DEXTRIN) CAPLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGISTAT-1</medicinalproduct>
        <drugbatchnumb>0096B</drugbatchnumb>
        <drugauthorizationnumb>20676</drugauthorizationnumb>
        <drugdosagetext>300 MG, ONCE/SINGLE, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PRIO50412007073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>40278</drugauthorizationnumb>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN T-GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904482</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>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE (DECITABINE) LYOPHILIZED POWDER</medicinalproduct>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>20 MG/M2, IN 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE (DECITABINE) LYOPHILIZED POWDER</medicinalproduct>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>20 MG/M2, IN 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT (ANTINEOPLASTIC AGENTS)</medicinalproduct>
        <drugdosagetext>400 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT (ANTINEOPLASTIC AGENTS)</medicinalproduct>
        <drugdosagetext>400 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALK_00433_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVITROL</medicinalproduct>
        <drugauthorizationnumb>21897</drugauthorizationnumb>
        <drugdosagetext>(380 MG 1X/MONTH INTRAMUSCULAR)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507074-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugindication>POSTOPERATIVE WOUND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000473</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>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MINIMUM INHIBITORY CONCENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS ENTEROCOCCAL</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507076-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101559</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>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, AT NIGHT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, AT NIGHT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, AT NIGHT</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROLIZED PENTAMIDINE (PENTAMIDINE) (AEROSOL FOR INHALATION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION (ANAGESICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVADENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101410</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG TITRATED EVERY 2 WEEKS UP TO 200 MG, NIGHTLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>20 MG/M2, D X 4-D PULSE, UP TO 3 PULSES /MONTH</drugdosagetext>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>20 MG/M2, D X 4-D PULSE, UP TO 3 PULSES /MONTH</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>G-CSF (GRANULOCYTE COLONY STIMULATING FACTOR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507079-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-249501</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>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>32 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN (UNITED STATES)</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN (UNITED STATES)</medicinalproduct>
        <drugdosagetext>162 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507080-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0422748-00</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDOBACTERIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA / CARBIDOPA HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERGOLIDE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ABBOTT-07P-130-0422521-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0422269-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00006</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF JOINT PROSTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00009</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00234</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507086-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0711SWE00001</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>20180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE EXAMINATION ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507087-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0710FRA00089</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>21549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</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>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE HEMISUCCINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIZAPRIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507088-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05718</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>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>021409</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507089-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA04527</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507090-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0708USA01139</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>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507091-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0710FRA00045</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE AND FORMOTEROL FUMARATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507092-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00013</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
        <drugtreatmentduration>874</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0705FRA00023</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLIDOCANOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VARICOSE VEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOCETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507094-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06965</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA02842</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOLET R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507096-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05064</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060727</drugenddate>
        <drugtreatmentduration>966</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507097-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0707USA02012</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>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507098-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA00660</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>221</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507099-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00005</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPEROSMOLAR COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIANEPTINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0710CAN00179</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507101-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA03621</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERAXIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507103-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL 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>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </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>065</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>5507104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA06877</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOOSPERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5507105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ABBOTT-07P-130-0422254-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE ORAL SOLUTION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18082</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-246174</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>125 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5507107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI021007</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>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022768</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32025</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016831</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-246174</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>125 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI015099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32018</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI014769</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>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32019</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI013940</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>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018659</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>46</patientonsetage>
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        <reactionmeddrapt>BRAIN TUMOUR OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32020</drugbatchnumb>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
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  <safetyreport>
    <safetyreportid>5507116-7</safetyreportid>
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    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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  <safetyreport>
    <safetyreportid>5507117-9</safetyreportid>
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      <reportercountry>THAILAND</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR AND RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022706</companynumb>
    <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>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022576</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>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI014628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060224</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000709</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022896</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>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI010492</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>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06090624</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>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
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        <drugdosagetext>100 MG, 1 IN 1 D, ORAL, 100MG-200MG, DAILY, ORAL</drugdosagetext>
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        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
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        <drugenddate>20051209</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL, 100MG-200MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
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  <safetyreport>
    <safetyreportid>5507126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</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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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL, 5 MG, 1 IN 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
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        <drugenddate>20070701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL, 5 MG, 1 IN 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
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        <drugstartdate>20070801</drugstartdate>
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  <safetyreport>
    <safetyreportid>5507127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101596</companynumb>
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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>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL, 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
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        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL, 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
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  <safetyreport>
    <safetyreportid>5507128-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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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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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL, 15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL, 15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507130-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101674</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>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD X 21 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056CB</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY X21 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>5Q-SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238729K07USA</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ZA17895</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>200 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>234974K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238115K07USA</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>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239252K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239014K07USA</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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238053K07USA</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>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADNEXA UTERI MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>3 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5507140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239205K07USA</companynumb>
    <primarysource>
      <reportercountry>ALBANIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (COTYLENOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10727</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>136.9</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>94 MG QD X 3 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugdosagetext>70 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>4700 MG QD X 3 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>3525 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYCARBOPHIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVINYL ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXY PLUS ALOE VERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXTZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GILEAD-2007-0013486</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE-DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTOVASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOLINE L112</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239174K07USA</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>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>8.8 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239167K07USA</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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239128K07USA</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL                  (OBETROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239084K07USA</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; 22 MCG; MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; 22 MCG; MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; 22 MCG; MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS                       (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239049K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239100K07USA</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239200K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239111K07USA</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>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GENENTECH-238105</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCRELIZUMAB</medicinalproduct>
        <drugbatchnumb>1431360</drugbatchnumb>
        <drugdosagetext>200 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050727</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D-07-0079</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANTOVEN</medicinalproduct>
        <drugauthorizationnumb>40416</drugauthorizationnumb>
        <drugdosagetext>GENERALLY 5 TO 7 MG (VARIED WITH INR), QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANTOVEN</medicinalproduct>
        <drugdosagetext>GENERALLY 5 TO 7 MG (VARIED WITH INR), QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPHEROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>62988</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE W/PARACETAMOL (PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CC07-183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>0110107</drugbatchnumb>
        <drugauthorizationnumb>72273</drugauthorizationnumb>
        <drugdosagetext>2 ACTUATIONS AS NEEDED</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABELLED DRUG-DISEASE INTERACTION MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NANDROLONE DECANOATE</medicinalproduct>
        <drugauthorizationnumb>86598</drugauthorizationnumb>
        <drugdosagetext>SINGLE</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>2 - 4 TABS OVER 2 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 TABLET, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>4-6 TABS OVER 2 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04771</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>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>72926</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMOTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN DECANOATE</medicinalproduct>
        <drugdosagetext>1 INJECTION Q MONTH</drugdosagetext>
        <drugindication>EMOTIONAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021874</companynumb>
    <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239226K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION (THYROID THERAPY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE (MORPHINE /00036301/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY (ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239118K07USA</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017745</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022258</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020205</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021416</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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020967</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QW; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>161776USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>61926</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSU-2007-00766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, QD), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX (RABEPRAZOLE SODIUM) (RABEPRAZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507168-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35103</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017663</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016868</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022334</companynumb>
    <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021092</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>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019238</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>FALLOPIAN TUBE CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; ; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022893</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QW; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022799</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>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AEUSA200700138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N8N31</drugbatchnumb>
        <drugdosagetext>12.5 GM;Q3W;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMBINED IMMUNODEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AEUSA200700237</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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugdosagetext>1 GM/KG;QW;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA NEONATAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AEUSA200700248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugdosagetext>2 G/KG; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PEMPHIGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200712313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMINAR-25</medicinalproduct>
        <drugbatchnumb>F948911</drugbatchnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018881</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP016537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWINRIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US002444</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>108.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313381-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugauthorizationnumb>62800</drugauthorizationnumb>
        <drugdosagetext>INTRAVITREAL INJECTION</drugdosagetext>
        <drugindication>EYE INFECTION TOXOPLASMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN                (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE DS             (BACTRIM /00086101/)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021646</companynumb>
    <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 FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021914</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>20950</drugauthorizationnumb>
        <drugdosagetext>75 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US08986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY SEDIMENT PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>65204</drugauthorizationnumb>
        <drugdosagetext>2 G DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN                                       (NGX)</medicinalproduct>
        <drugdosagetext>1G, Q12H, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN                   (ISOPHANE INSULIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US08985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>65204</drugauthorizationnumb>
        <drugdosagetext>2 G, Q12H, INTRAVENOUS, 1 G, Q12H, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>65204</drugauthorizationnumb>
        <drugdosagetext>2 G, Q12H, INTRAVENOUS, 1 G, Q12H, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, Q12H, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>016662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US08989</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRN</medicinalproduct>
        <drugauthorizationnumb>76192</drugauthorizationnumb>
        <drugdosagetext>1200 MG, DAILY</drugdosagetext>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A(PEGINTERFERON ALFA-2A)</medicinalproduct>
        <drugdosagetext>180 UG WEEKLY</drugdosagetext>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>015593</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugauthorizationnumb>20718</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021551</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>CATHETER THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugauthorizationnumb>20718</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10718</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERDYNAMIC PRECORDIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2 QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL. MFR: MCNEIL LABORATORIES, INCORPORATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL. MFR: PARKE, DAVIS AND COMPANY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA. MFR: SQUIBB E.R. + SONS, INCORPORATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR. MFR: PARKE, DAVIS AND COMPANY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KADN20070098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021814</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>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>6RXF28BDE</drugbatchnumb>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTNASAL DRIP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021162</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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>7607PP</drugbatchnumb>
        <drugauthorizationnumb>22015</drugauthorizationnumb>
        <drugdosagetext>1 DF; ONCE; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021672</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>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASBESTOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL /00139501/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07-002137</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>76.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMCON FE</medicinalproduct>
        <drugbatchnumb>00JUN2007</drugbatchnumb>
        <drugauthorizationnumb>21490</drugauthorizationnumb>
        <drugdosagetext>0.4MG/35MCG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMCON FE</medicinalproduct>
        <drugbatchnumb>00JUN2007</drugbatchnumb>
        <drugauthorizationnumb>21490</drugauthorizationnumb>
        <drugdosagetext>0.4MG/35MCG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN 24 FE</medicinalproduct>
        <drugbatchnumb>01787F</drugbatchnumb>
        <drugdosagetext>20/1000 UG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN 24 FE</medicinalproduct>
        <drugbatchnumb>01787F</drugbatchnumb>
        <drugdosagetext>20/1000 UG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021856</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-007480-07</companynumb>
    <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>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-008422-07</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1750 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>1750 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>360 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>535 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507236-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>576 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>38 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507237-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>20MG DAILY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507238-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAEVUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORCHITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLD BOND HEALING MEDICATED BODY POWDER</medicinalproduct>
        <drugbatchnumb>0073545-01</drugbatchnumb>
        <drugdosagetext>ONE DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLD BOND HEALING MEDICATED BODY POWDER</medicinalproduct>
        <drugbatchnumb>3B-2278-A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLD BOND HEALING MEDICATED BODY POWDER</medicinalproduct>
        <drugbatchnumb>05421T</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507240-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>M324A</drugbatchnumb>
        <drugdosagetext>100CC 2CC PER/SEC RT AC</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0059C-A</drugbatchnumb>
        <drugdosagetext>10MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507242-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0165</drugbatchnumb>
        <drugdosagetext>1 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300MG TID P.O.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CITRATE</medicinalproduct>
        <drugdosagetext>300 MG TID P.O.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugbatchnumb>MYLAN147</drugbatchnumb>
        <drugdosagetext>50MG TWICE DAILY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG DAILY FEEDING TUBE</drugdosagetext>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.0208</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, 2 TABS TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG PO QDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>99.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50MG PO BID ESTIMATED DURATION OF USE OF 2-3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
        <drugdosagetext>40MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
        <drugdosagetext>40MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN LACERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>1156652</drugbatchnumb>
        <drugdosagetext>430MG DIVIDED DOSES IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugdosagetext>600 MG PO Q8HRS 3 DOSES ORG 1 ON 10/30</drugdosagetext>
        <drugindication>CELLULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>CN329137</drugbatchnumb>
        <drugdosagetext>35 MG WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>CN329137</drugbatchnumb>
        <drugdosagetext>35 MG WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.25MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507254-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG 1 X EA DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG 1X EA DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG 1X EA DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX18034</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007PH18378</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>017851</drugauthorizationnumb>
        <drugdosagetext>25 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>017851</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>25 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18018</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03615</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507260-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03153</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugdosagetext>2.1 G, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14260</companynumb>
    <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>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507262-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NL18170</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT17852</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugauthorizationnumb>21014</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DK18205</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507266-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>CASUAL USE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/20 MG QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOGEN</medicinalproduct>
        <drugdosagetext>1 TAB DAILY FOR 84 NITES STOP FOR 7 NITES THEN 84 ON 7 OFF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507268-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>1 PILL 1 X WEEKLY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507269-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>M3240</drugbatchnumb>
        <drugdosagetext>100 CC 2 CC PER SEC LTAC</drugdosagetext>
        <drugindication>SCAN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02185</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507271-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14298</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>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507272-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14263</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>17963</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14265</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507274-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14312</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>66.213</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugauthorizationnumb>011793</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507275-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11741</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>FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP14804</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-VG</medicinalproduct>
        <drugindication>RADIATION SKIN INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AU18016</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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1040 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DAYDREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007PL03654</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>EYELID OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17749</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FP</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14304</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007BG03253</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</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>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>650 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13319</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507285-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12045</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007SI03617</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>100-100-200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PORTAL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP11798</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>0.5MG/KG/DOSE X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOGENESIS IMPERFECTA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050327</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>0.5MG/KG/DOSE X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14105</companynumb>
    <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>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>020313</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18198</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>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORLOSE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>40 IU/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007SI03632</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSELEX EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>21513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLIPREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US08456</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>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>20823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070513</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070513</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX18201</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB01932</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 DF, QID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP07001725</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAOCULAR MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LUXATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORONAL /00802602/ (BISOPROLOL, FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D /00107901/ (ERGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAURIN (DIAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRP07000999</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURADANTIN</medicinalproduct>
        <drugdosagetext>150 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAONIL (GLIBENCLAMIDE)</medicinalproduct>
        <drugdosagetext>15 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM /01479302/(ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
        <drugdosagetext>20 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIATEC /00885601/(RAMIPRIL)</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL /000300001/(PROPRANOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON /00023503/ (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE /00082701/ (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD /00030504/ (INSULIN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX /00889602/ (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE /01420901/ (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX /00032601/ (FUROSEMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021335</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>TIW; TIW</drugdosagetext>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>TIW; TIW</drugdosagetext>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20070245</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugauthorizationnumb>21135</drugauthorizationnumb>
        <drugdosagetext>300 MG WITHIN 1 HOUR INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH007981</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </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>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0703012</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007GB03592</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710USA05461</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>70 MG/1X IV, 50 MG/DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>70 MG/1X IV, 50 MG/DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493210A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200717565GDDC</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022655</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB (NATALIZUMAB)</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-JNJFOC-20071006902</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE (DECITABINE) LYOPHILIZED POWDER</medicinalproduct>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>29 MG, INTRAVENOUS; 29 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE (DECITABINE) LYOPHILIZED POWDER</medicinalproduct>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>29 MG, INTRAVENOUS; 29 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODAMINT (SODIUM BICARBONATE) UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000154</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>CEREBRAL TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG; 0.2 MG/KG</drugdosagetext>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG; 0.2 MG/KG</drugdosagetext>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP014134</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG;QW;SC ; 80 MCG;QW;SC ; 50 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG;QW;SC ; 80 MCG;QW;SC ; 50 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG;QW;SC ; 80 MCG;QW;SC ; 50 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP007755</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGETRON (PEGINTERFERON ALFA-2B W/RIBAVIRIN) (PEGYLATED INTERFERON ALF</medicinalproduct>
        <drugdosagetext>150 MCG;QW;SC 1200 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGETRON (PEGINTERFERON ALFA-2B W/RIBAVIRIN) (PEGYLATED INTERFERON ALF</medicinalproduct>
        <drugdosagetext>150 MCG;QW;SC 1200 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>5RMKA72001</drugbatchnumb>
        <drugdosagetext>482.5 MG;ONCE;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTEC-30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMOL HC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000153</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG; QD; 0.2 MG/KG; QD</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG; QD; 0.2 MG/KG; QD</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021374</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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>8.55 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM REPLACEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM REPLACEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507316-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23321BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12245</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000063</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>OT001626</drugbatchnumb>
        <drugdosagetext>5 IU; X1 IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>OT001626</drugbatchnumb>
        <drugdosagetext>5 IU; X1 IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>16.2 ML; X1; IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>16.2 ML; X1; IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507319-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12247</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09203</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST(ETHINYLESTRADIOL, NORGESTIMATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-0712115US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>120 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>120 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSCODE</medicinalproduct>
        <drugdosagetext>27 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010749</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76540</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507323-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021932</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>4 MG;QD</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2 GM;QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN (PROPOFAN /01607901/)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019583</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>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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMADORM (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEANXIT (CON.)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01766</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL (UNSPECIFIED) (CLOBETASOL PROPIONATE) (CLOBETASOL PROPIONAT</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163069ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050915</drugenddate>
        <drugtreatmentduration>577</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507329-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163072ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN SMALL INTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>74390</drugauthorizationnumb>
        <drugdosagetext>150 MG (50 MG,3 IN 1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERINEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007223</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOSUFLOXACIN TOSILATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507331-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.01</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706119</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070204674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>200 MG IN AM, 100 MG IN PM</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 DOSE=1 PILL</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071007479</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>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DURATION FOR AT LEAST 3 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070704136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070107733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATED MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071100730</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM ADVANCED</medicinalproduct>
        <drugbatchnumb>784395</drugbatchnumb>
        <drugauthorizationnumb>021140</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM ADVANCED</medicinalproduct>
        <drugbatchnumb>784395</drugbatchnumb>
        <drugauthorizationnumb>021140</drugauthorizationnumb>
        <drugdosagetext>2-4 CAPLETS PER DAY AS NEEDED</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507338-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163228ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>18679</drugauthorizationnumb>
        <drugdosagetext>(200 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGAPTANIB SODIUM</medicinalproduct>
        <drugdosagetext>(300 MCG)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163005ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN SMALL INTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>74390</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20071007965</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006742</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070905129</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>18 INFUSION ON UNSPECIFIED DATES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163120ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76136</drugauthorizationnumb>
        <drugdosagetext>1000 MG (500 MG, 2 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163063ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>40333</drugauthorizationnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM FOLINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507354-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-0712130US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>100 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>TORTICOLLIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02507</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>ELECTROCARDIOGRAM AMBULATORY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>1.5 G DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NL18285</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>19667</drugauthorizationnumb>
        <drugindication>CARCINOID SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (NGX)</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCOR</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBIN ^AMSTERDAMSE CHININEFABRIK^</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02893</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019130</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>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30800_2007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMIPRAMINE (TRIMIPRAMINE) 100 MG</medicinalproduct>
        <drugdosagetext>(1000 MG 1X NOT THE PRESCRIBED AMOUNT.  ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30552_2007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(0.5 MG BID ORAL), (1 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11244</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>
      <patientweight>11.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugbatchnumb>A 7040 H03</drugbatchnumb>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugbatchnumb>A 7040 H14</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021395</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021760</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </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>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-266542</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>TP51379</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>18 + 18 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE404622JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507372-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-WYE-H00899007</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE131913SEP07</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP017797</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>170 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROMORPH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007039</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007050</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071003633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01768</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507388-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01743</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01742</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713567BCC</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>239227A</drugbatchnumb>
        <drugdosagetext>UNIT DOSE: 15 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01739</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01738</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL (UNSPECIFIED) (CLOBETASOL PROPIONATE) (CLOBETASOL PROPIONAT</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200720117GDDC</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 25 TO 30</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>B208</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717079US</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 13 IN AM AND 20 IN PM</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK GREY</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>B021</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 20 AT NIGHT AND 14 IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200716251US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>B017</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>B017</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 3, SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 4 AT LUNCH, SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 5, SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAXIA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                            /00972401/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC                            /00935901/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717054US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PREPARATIONS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268496</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 FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>8 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>4 -12 IU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN                             /00082702/</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2007-0134</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, PERSECUTORY TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EFFECT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>500 MG (100 MG, 5 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELEGILINE HCL</medicinalproduct>
        <drugdosagetext>7.5 MG (2.5 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>6 MG (2 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>6 MG (2 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>6 MG (2 MG, 3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILMAG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2007-0143</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-WYE-G00561307</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE945125MAY05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-UK239336</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>N1174AL01</drugbatchnumb>
        <drugauthorizationnumb>007413</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTIBIOTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2007-0126</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>300 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EFFECT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021107</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>432</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
        <drugtreatmentduration>440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>468</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPACOL</medicinalproduct>
        <drugdosagetext>4.5 DF/D ORA; 5 DF/D ORAL; 5.5 DF/D ORAL; 6.5 DF/D ORAL; 8 DF/D ORAL; 7 DF/D ORAL; 6 DF/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>162986ISR</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>75184</drugauthorizationnumb>
        <drugdosagetext>300 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13963947</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>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5507423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13967757</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</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>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>062336</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13968177</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>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICOAGULATION DRUG LEVEL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 5MG , 1.5 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13591243</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>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INITIAL DOSE - 10-OCT-2006;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>INITIAL DOSE - 10-OCT-2006;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13969720</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-13968763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE ON 08-FEB-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugdosagetext>INITIAL DOSE WAS GIVEN ON 08-FEB-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13968490</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugauthorizationnumb>18207</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13969472</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICNU</medicinalproduct>
        <drugauthorizationnumb>017422</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
        <drugdosagetext>1DF=37G/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugdosagetext>ALSO TAKEN FROM NOV2003 TO JUN2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13967070</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>DOSE 750 MG ON 01-OCT-2007 AND 31-OCT-2007.</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugdosagetext>MOST RECENT ADMNISTRATION ON 31-OCT-2007.</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13801246</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>LAST ADMINISTERED DATE 29 MAY 2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>LAST ADMINISTERED ON 29 MAY 2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>1 DOSAGE =7000CGY IN 35 FRACTIONS</drugdosagetext>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU248278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SHR-SE-2007-027233</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019865</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAPACE AF</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAPACE AF</medicinalproduct>
        <drugdosagetext>480 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AMGEN-UK250063</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>1002350</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25284</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGUA OXIGENADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB01574</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>017970</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2004UW06681</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>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040329</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIDRADENITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710007234</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>021520</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002829</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000638</companynumb>
    <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200711000003</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000259</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK248793</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK245521</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>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAYER-200716527GDS</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715046GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713953BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715044GDS</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715042GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715051GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715050GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714079BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714015BWH</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200715041GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714010BWH</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163065ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
        <drugauthorizationnumb>75149</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE</medicinalproduct>
        <drugauthorizationnumb>75149</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163061ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>61926</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-UK244719</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AMGEN-UK249973</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163027ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>76017</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-162642-NL</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL (BATCH #: 928895 / 951189)</medicinalproduct>
        <drugauthorizationnumb>21529</drugauthorizationnumb>
        <drugdosagetext>DF, SUBDERMAL</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-JNJFOC-20071007570</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C3 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-JNJFOC-20071100414</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>4TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>3 INFUSIONS, DATES UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6038364</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCOR (TABLET) (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC (TABLET) (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PADMED CIRCOSAN (TABLET) (CAMPHOR,  CALCIUM SULFATE, ACONITUM NAPELLUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TUK2007A00121</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507475-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100124</companynumb>
    <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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>30MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON DAYS 1, 4, 8 AND 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101285</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070905126</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071002110</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2 MG IN THE MORNING AND 4 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG IN THE MORNING AND 4 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>0.5 MG IN THE MORNING AND 1 MG AT 7.00PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTISM SPECTRUM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEDATIF PC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-IRL-05572-01</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_00627_2007</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>COOMBS POSITIVE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO (APO-GO PFS 5 MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>HOUR FOR 5 YEARS 5 MONTHS FOR 12 HOURS PER DAY SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR /00349201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASAGILINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507482-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200710573BFR</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IZILOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IZILOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRILENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BAYER-200716468GDS</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOSPERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019847</drugauthorizationnumb>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713656BWH</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>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004523</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76033</drugauthorizationnumb>
        <drugdosagetext>500 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004524</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>74936</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONI JUICE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENAZON-KOFFEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX /NOR/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071006739</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>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS A DAY (IN THE EVENING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070802475</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712946JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5507490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004525</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUBELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>77345</drugauthorizationnumb>
        <drugdosagetext>50 MG; QD;</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOLIFE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004526</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76033</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACOMPLIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004518</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76241</drugauthorizationnumb>
        <drugdosagetext>30 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5507493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071029</receiptdate>
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    <companynumb>GB-AVENTIS-200720076GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugauthorizationnumb>017532</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5507494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720084GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugauthorizationnumb>017532</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5507495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071029</receiptdate>
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    <companynumb>GB-AVENTIS-200720092GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugauthorizationnumb>017532</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5507496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <companynumb>FR-AVENTIS-200713441FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00789001/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
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        <drugstartdate>20040101</drugstartdate>
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        <drugenddate>20070505</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070505</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
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        <drugstartdate>20040101</drugstartdate>
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        <drugenddate>20070505</drugenddate>
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    <safetyreportid>5507497-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedate>20071102</receivedate>
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    <receiptdate>20071019</receiptdate>
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    <companynumb>DSJ-2007-06468</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXIC EPIDERMAL NECROLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 D), PER ORAL;</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEGACIN (BIAPENEM) (INJECTION) (BIAPENEM)</medicinalproduct>
        <drugdosagetext>600 MG (300 MG, 2 IN 1 D), INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOSEGON (PENTAZOCINE) (INJECTION) (PENTAZOCINE)</medicinalproduct>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>AS NEEDED (25 MG), PER RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>HYPERTHERMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF (INJECTION)</medicinalproduct>
        <drugdosagetext>800MG, 400MG (2 IN 1 D), INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>2 GM (1 GM, 2 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710004077</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugdosagetext>12 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709005265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.793</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL/CALCIUM PHOSP/CALCIUM SOD LACT</medicinalproduct>
        <drugdosagetext>800 IU, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200710005829</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A342454</drugbatchnumb>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D) (AT NOON EVERY DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE W/COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>UNK UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708005349</companynumb>
    <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>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200702005816</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYLIN</medicinalproduct>
        <drugdosagetext>160 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1830</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1834</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>4.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>1 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1638</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN /JPN/</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1638</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1386</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>250 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070303</drugenddate>
        <drugtreatmentduration>572</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1647</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A355346</drugbatchnumb>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710007118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006161</companynumb>
    <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 DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005495</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>375 MG, Q 21 D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-IRON</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03424</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060605</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03548</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>CONTRACTED BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE015602FEB05</companynumb>
    <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>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19881001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0421676-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTERITIS NODOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>68.0396</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>3.125 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>82.1011</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB   UNKNOWN    UNKNOWN</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugbatchnumb>DEA#BM7400372</drugbatchnumb>
        <drugdosagetext>10 MG. DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>TOO LONG AGO TO REMEMBER</drugdosagetext>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970804</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01741</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 30</medicinalproduct>
        <drugbatchnumb>2215002</drugbatchnumb>
        <drugdosagetext>30MG ONE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 30</medicinalproduct>
        <drugbatchnumb>2215002</drugbatchnumb>
        <drugdosagetext>30MG ONE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugdosagetext>CATAPRES TTS3 PATCH EVERY 7TH DAY TRANSDERMAL;  CATAPRES TTS1 PATCH EVERY 7TH DAY TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugdosagetext>CATAPRES TTS3 PATCH EVERY 7TH DAY TRANSDERMAL;  CATAPRES TTS1 PATCH EVERY 7TH DAY TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01740</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugdosagetext>25MG  DAILY X 21D/28D  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREPARATION H OINTMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>PROPHYLAXIS URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01736</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELASTOSIS PERFORANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugdosagetext>25MG  DAILY  X21D/28D   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugindication>STRESS ECHOCARDIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01737</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELASTOSIS PERFORANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>75057</drugauthorizationnumb>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB   10MG/KG    GENENTECH</medicinalproduct>
        <drugbatchnumb>N51410</drugbatchnumb>
        <drugdosagetext>450MG  Q2WKS  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>1 TIME A DAY</drugdosagetext>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05209-01</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>AMT. PRESCRIBED DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070302143</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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>38 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-JPN-05603-01</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507533-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>1 CC  DAILY  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>X1   IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05474-01</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>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>20 MG  DAILY  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUZOLE</medicinalproduct>
        <drugdosagetext>50 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUZOLE</medicinalproduct>
        <drugdosagetext>50 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200719939GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717714US</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AVENTIS-200719352GDDC</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugdosagetext>DOSE QUANTITY: 1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXIN                           /00697201/</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200 MG   1 TAB-WEEK-1 TAB  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200 MG   1 TAB-WEEK-1 TAB  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-NLD-05291-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>30 MG QD</drugdosagetext>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>125 MG QD</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG QD</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERSIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugdosagetext>VAG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650MG  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650MG  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650MG  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-AUT-05676-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTHIPENDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>55.3388</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>ONE CAPSULE  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>ONE CAPSULE  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200616770BWH</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (NOS)</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 0.2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 160 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 0.4 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>AS USED: 0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 TABLET   2-3 TIMES PER DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>28.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENYLCYCLOPROPENONE  0.5%</medicinalproduct>
        <drugdosagetext>WEEKLY  TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA TOTALIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05619-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA FOETAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HYPERTONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPESS (DINOPROSTONE)</medicinalproduct>
        <drugauthorizationnumb>20411</drugauthorizationnumb>
        <drugdosagetext>10 MG ONCE VG</drugdosagetext>
        <drugindication>LABOUR INDUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIDURAL ANESTHETIC DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NLD-05680-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX (INSULIN ASPART)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.09</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>5JFL3</drugbatchnumb>
        <drugdosagetext>2030 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-UKI-05681-01</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>972 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>97 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-358047</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040108</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>3200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-523452</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HCL</medicinalproduct>
        <drugdosagetext>5/500 TWO TABLETS TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG THREE TABLETS BID PRIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-529436</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-466960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM NOS</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ETHINYL ESTRADIOL/NORETHINDRONE (ORTHO NOVUM).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-495935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIDESILON</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-527863</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>17533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRONTALGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS: INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS THIRD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS THIRD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 20 MG THIRD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-496863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS SOLDEM 1.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOMIRON</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>DOSE FORM REPORTED AS ORAL FORMULATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-509163</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAVENOUS DRIP. ADDITIONAL INDICATIONS: REJECTION ACUTE RENAL; BONE MARROW FAILURE; PULMON+</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAVENOUS (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAVENOUS (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE</medicinalproduct>
        <drugdosagetext>REPORTED AS ADRENAL HORMONE PREPARATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-479447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR II 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>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>LYMPHOID TISSUE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19850201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19911024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLISTEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</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>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>056-C5013-07020646</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-07100122</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL; 50 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL; 50 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-479480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</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>19850601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-394796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYCLOTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MEMBRANOPROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS M-W-F</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: AT BED TIME (QHS).</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
        <drugdosagetext>DOSAGE REPORTED AT BED TIME (QHS).</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINCIPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVACET</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS SUSPENSION RINSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20070902863</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007439</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>PLEURAL FIBROSIS</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-21880-07070715</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, EVERY 2 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSFUSIONS (RED BLOOD CELLS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN-GUTTAE (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLUT (PREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MST (MORPHINE SULFATE) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-C5013-07061280</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>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACETABULUM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL RUB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</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>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD X21 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250512</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DISSEMINATED CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, 1/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>229-C5013-07081217</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>BLOOD CHLORIDE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL ; 15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL ; 15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>20 MG, EVERY 2/52</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUMIL (FRUMIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALAN (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDOSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSFUSION (BLOOD TRANSFUSION, AUXILIARY PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1380 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>74 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>690 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_00799_2007</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 ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO (APO-GO PFS 5 MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>(100 MG PER DAY SUBCUTANENOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-BENELDOPA (MADOPAR DISPERSIBLE (CO-BENELDOPA))</medicinalproduct>
        <drugdosagetext>(250 MG ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET-PLUS (SINEMET PLUS (CO-CARELDOPA)) (NOT SPECIFIED)</medicinalproduct>
        <drugdosagetext>(375 MG ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugdosagetext>(250 MG ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE (UNKNOWN UNTIL UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE (UNKNOWN UNTIL UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL (UNKNOWN UNTIL UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL (UNKNOWN UNTIL UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (UNKNOWN UNTIL UNKNOWN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>16 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>38 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>34.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1280 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>3.6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE HCL</medicinalproduct>
        <drugdosagetext>14 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-SWE-05702-01</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIMOL (TIMOLOL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPARKAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDEOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOLVIDON (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL (ALFUZOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-BDI-010078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>5040 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>720 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>153 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NLD-05216-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200700673</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>FACTOR VIII DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS, 1.75MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LASER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS, 1.75MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LASER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROLONGED EXPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>107.00, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-02344</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>94.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARBON MONOXIDE DIFFUSING CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORCED EXPIRATORY VOLUME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE(VELCADE) INJECTION, VELCADE (BORTEZOMIB) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.75 MG, IV BOLUS, 1.47 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE(VELCADE) INJECTION, VELCADE (BORTEZOMIB) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.75 MG, IV BOLUS, 1.47 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB(RITUXIMAB) INJECTION, 375MG/M2</medicinalproduct>
        <drugdosagetext>800.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>630.00, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2.00 MG, 2.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugdosagetext>106.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1.58 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE(METHOTREXATE SODIUM) INJECTION</medicinalproduct>
        <drugdosagetext>1680.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250650</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>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200700678</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS, 1.75 MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-NO-0710S-1295</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>100 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0710S-0420</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>10 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A01958</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (PARACETAMOL, HYDROCODONE BITARTRATE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL (FENTANYL) (POULTICE OR PATCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0604S-0100</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>49 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0604S-0112</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>40 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.249</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N24530/ N38279</drugbatchnumb>
        <drugdosagetext>1320 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>420 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>370 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03555</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>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03617</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>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-01335</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100.00 , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>100.00, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070325</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02170</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>45 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP07000227</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL(MESALAMINE) UNKNOWN, UNKNOWNING</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02167</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>118.8424</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200720106GDDC</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABORTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021931</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC INTRACRANIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200719906GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL                           /00582602/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, HS, PER ORAL, 16 MG, 2 AT ONCE, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021881</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG,QW;PO, 1200 MG/QW;PO,200 MG,TIW;PO, 200 MG,BIW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG,QW;PO, 1200 MG/QW;PO,200 MG,TIW;PO, 200 MG,BIW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG,QW;PO, 1200 MG/QW;PO,200 MG,TIW;PO, 200 MG,BIW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG,QW;PO, 1200 MG/QW;PO,200 MG,TIW;PO, 200 MG,BIW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>135 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02198</companynumb>
    <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>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, ONCE, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021618</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02166</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001853</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM IONISED DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASTIC NAEVUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITROL (ERGOCALCIFEROL, RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE/SALICYLIC ACID ONTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP01652</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATONIN-O</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL ELIXIR</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2007PK02251</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20455</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB00793</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23760</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>66.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE 1% WITH ADRENALINE</medicinalproduct>
        <drugbatchnumb>9922255</drugbatchnumb>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>INFILTRATION SUB CUT; 1:200,000. 2.5 ML TO LOWER EYELIDS</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE 1% WITH ADRENALINE</medicinalproduct>
        <drugbatchnumb>9922255</drugbatchnumb>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugdosagetext>INFILTRATION SUB CUT; 1:200,000. 2.5 ML TO LOWER EYELIDS</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06435</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29702</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDITRANS</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONOACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDOPA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEISHOKU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDOPA</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.1</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNKNOWN DIVIDED DOSE FREQUENCY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20070241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30.391</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugauthorizationnumb>21135</drugauthorizationnumb>
        <drugdosagetext>58 MG, IV Q MONTH</drugdosagetext>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN NOVO REGULAR</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ASTRAZENECA-2007SE05669</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CURANTYL</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CURANTYL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILDRONATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILDRONATE</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOVEGIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOVEGIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06900</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14067</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>14 TABLETS TAKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>14 TABLETS TAKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>14 TABLETS TAKEN</drugdosagetext>
        <drugadministrationroute>048</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>CONSTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ASTRAZENECA-2007AC01230</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29841</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugauthorizationnumb>021324</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19770101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL CARDIO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06741</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE HYDROCHLORIDE PRESERVATIVE FREE</medicinalproduct>
        <drugauthorizationnumb>071202</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL ELIXIR</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE05507</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26517</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06930</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002473</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 MG, TID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugbatchnumb>001850799-60</drugbatchnumb>
        <drugdosagetext>300MG  ONCE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS SKIN TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0059C-A</drugbatchnumb>
        <drugdosagetext>10MG  DAILY 21D/28D   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEEP SEA NASAL SPRAY     PROPHARMA INC.</medicinalproduct>
        <drugbatchnumb>E4844M</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002182</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ATOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.03%, BID, TOPICAL, 0.03%, UID/QD, TOPICAL, 0.03%, 3XWEEKLY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>15.4223</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 300</medicinalproduct>
        <drugdosagetext>100 ML  ONE TIME   IV</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSU-2007-00793</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, QD), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL) (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010744</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77039</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.9989</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100MG  TWICE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>57.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG  ONCE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>93.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE101909AUG04</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>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE002719MAY04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE095314JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-266782</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>.3 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL                            /00028601/</medicinalproduct>
        <drugdosagetext>8-20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMIFLU                            /01400102/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-257369</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>78 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060918</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060924</drugenddate>
        <drugtreatmentduration>297</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>44 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060913</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>60 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugdosagetext>34 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN                         /00546001/</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060529</drugenddate>
        <drugtreatmentduration>238</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060226</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugdosagetext>.125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790701/</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3-3.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060913</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>71.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE    200</medicinalproduct>
        <drugdosagetext>100 CC  ONE TIME  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268888</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268886</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268906</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>ANTI-INSULIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268880</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>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN AUTOIMMUNE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268011</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <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>NORDITROPIN NORDIFLEX</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>5.3 - 6 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>924</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268914</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-268827</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugindication>SPINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOTEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-268997</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>30 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>20 -30 IU, PREMEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>78 IU, (24IU+26IU+28IU)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>69 IU, (22IU+20IU+27IU)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007513</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>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0701897</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007687</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007698</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007699</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071100028</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTUSS INFANTS DECONGESTANT + COUGH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL DECONGESTION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTUSS INFANTS DECONGESTANT + COUGH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071007008</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DAYDREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugauthorizationnumb>19735</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>804</patientonsetageunit>
      <patientweight>1.72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOPROFEN</medicinalproduct>
        <drugdosagetext>8 MG ONCE  -LOADING DOSE- IV BOLUS 4MG Q24H X 2 IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PATENT DUCTUS ARTERIOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN/FAT EMULSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.2867</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>D7CO75</drugbatchnumb>
        <drugdosagetext>143MG  EVERY 3 WEEKS   IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.1022</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>150MG  ONCE A DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>150MG  ONCE A DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100MG ONCE A DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP TERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0380991A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0656856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICOURETERIC REFLUX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAOPECTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICK VAPORUB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0664046C</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>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYL ACID</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682849A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687550A</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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688518A</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>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44MCG THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690773A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690774A</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20358</drugauthorizationnumb>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIET PILL UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690788A</companynumb>
    <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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>7ZP4934</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691023A</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359410A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359411A</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359417A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359418A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0454969A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHYLMALONIC ACIDURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>RETROVIRAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>230</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0469529A</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>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORCHIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTIS CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugdosagetext>1400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESANBUTOL</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0481986A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>200MG FIVE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485348A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485967A</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>200MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486619A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>250MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPRENALINE HCL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486949A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMINO ACID LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHYLMALONIC ACIDURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>4MGK TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487804A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488658A</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>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>2.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUQUINON</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>2.01G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491205A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>48MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492156A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OLIGURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRONON</medicinalproduct>
        <drugdosagetext>150MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492607A</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</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>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492626A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492627A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493006A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493389A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</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>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN(MOL.WT.UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493569A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATABON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493573A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493764A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROTIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>320MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493794A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIGORO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>2 TABS 1 TIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493852A</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COROPRES</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>9.3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493925A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1875MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493944A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>19389</drugauthorizationnumb>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>200MCG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493951A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50754</drugauthorizationnumb>
        <drugdosagetext>1UNIT SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493966A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIAZINE</medicinalproduct>
        <drugdosagetext>5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHORIORETINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHORIORETINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACINE</medicinalproduct>
        <drugdosagetext>600MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KESTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493982A</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493994A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugdosagetext>12G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>3G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE + OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494081A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>21071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE AND METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE SPRAY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL CFC FREE</medicinalproduct>
        <drugdosagetext>200MCG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494128A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</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>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494136A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0053210A</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINORM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIOFOR</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
        <drugtreatmentduration>270</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054457A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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 BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0685526A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS E-X TABLETS, ASSORTED FRUIT</medicinalproduct>
        <drugbatchnumb>1A29</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691407A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691426A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7C28D</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691568A</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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7F05</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>74.8435</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG ONCE DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 OR 750 MG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGER BALM (SPORTS BALM ULTRA STRENGTH)</medicinalproduct>
        <drugbatchnumb>51009</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS 1 TIME</drugdosagetext>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGER BALM (SPORTS BALM ULTRA STRENGTH)</medicinalproduct>
        <drugbatchnumb>51009</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS 1 TIME</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGER BALM (SPORTS BALM ULTRA STRENGTH)</medicinalproduct>
        <drugbatchnumb>51009</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS 1 TIME</drugdosagetext>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGER BALM (SPORTS BALM ULTRA STRENGTH)</medicinalproduct>
        <drugbatchnumb>51009</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS 1 TIME</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUBBORNNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE 500 MG PLIVA, INC. / CVS</medicinalproduct>
        <drugbatchnumb>RX 536065</drugbatchnumb>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 PILL TWICE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>300MG PO TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000050</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>76448601</drugbatchnumb>
        <drugdosagetext>5 IU;X1;IVB; 5 IU;X1;IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>76448601</drugbatchnumb>
        <drugdosagetext>5 IU;X1;IVB; 5 IU;X1;IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>9.5 ML;X1;IVB; 21.6 ML;X1;IV</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>9.5 ML;X1;IVB; 21.6 ML;X1;IV</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
        <drugdosagetext>2 SPAYS EACH NOSTRIL TWICE A DAY NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MYCOTIC ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG PER DAY SAME TIME PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10.4327</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEDIACARE DECONGESTANT + INFANT DROPS PEDIACARE</medicinalproduct>
        <drugbatchnumb>14PUT</drugbatchnumb>
        <drugdosagetext>1.2 ML 4-6 HOURS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugbatchnumb>Q8387005</drugbatchnumb>
        <drugdosagetext>300MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANTOVEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>140.6151</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE884806JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</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>PROVERA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00316-SPO-DE</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>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1 IN 1 D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>I CAN' ' T READ</drugbatchnumb>
        <drugdosagetext>1 - 60 MG TABLET 1 PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CLOSTRIDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>110 MG IV Q 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXETIMEBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAXZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS S04</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH ILETIN II</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLOROPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00305-SPO-JP</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM (BENZBROMARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT (URALYT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL (TIAPRIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B (LACTOBACILLUS BIFIDUS, LYOPHYLIZED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE-R (VALPROTE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB, 100MG TABLETS, NOVARTIS</medicinalproduct>
        <drugbatchnumb>F0028</drugbatchnumb>
        <drugdosagetext>350MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02893</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSURETHRAL PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25421</companynumb>
    <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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB00794</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16324</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>82.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE 1% WITH ADRENALINE</medicinalproduct>
        <drugbatchnumb>DY250</drugbatchnumb>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>1:200,000; 5 ML EACH EYE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE 1% WITH ADRENALINE</medicinalproduct>
        <drugbatchnumb>DY250</drugbatchnumb>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugdosagetext>1:200,000; 5 ML EACH EYE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00336-SPO-JP</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>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENITOIN (PHENYTOIN)</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>15/500 X 2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5- 1 MG Q 6 H PRN</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000323</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>5 IU;X1;IV; 5 IU;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugdosagetext>5 IU;X1;IV; 5 IU;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugdosagetext>10 ML;X1;IV; 250 ML; ;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugdosagetext>10 ML;X1;IV; 250 ML; ;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>110 MG IV Q 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33.294</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>55400DD</drugbatchnumb>
        <drugdosagetext>1250 MG EVERY 12 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>56-982-Z7</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2090-00331-SPO-AT</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>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>300 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRAZEPAM (LEVETIRACETAM)</medicinalproduct>
        <drugdosagetext>3000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>3500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPIN (QUETIAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>10381915</drugbatchnumb>
        <drugdosagetext>100 CC ONCE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5MG -3 OF THE 2.5MG- EVERY DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>
        <drugindication>ENTEROCUTANEOUS FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6MP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007549</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</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>VASCULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20071007764</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>700 UNIT, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01512</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28954</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>1507</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06865</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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02207</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>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>144-20785-07051072</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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 M G, 2 IN 1 D, ORAL; 100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 M G, 2 IN 1 D, ORAL; 100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-21880-07091286</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCLONAL IMMUNOGLOBULIN PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL; 15 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL; 15 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTAGAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCYTES CONCENTRATE (RED BLOOD CELLS, CONCENTRATED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBOCYTES CONCENTRATE (PLATELETS, CONCENTRATED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250391</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>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US250700</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>5088</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>3 MG/KG INTERMITTENT INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250140</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US243522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1.25MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>32.5MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GENENTECH-250003</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09178</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL (DIHYROCHODEINE BITARTRATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL (ISPAGHULA, PLANTAGO OVATA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA, SENNA ALEXANDRINA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249685</companynumb>
    <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>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE MALUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P098321</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE816415OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE944523FEB06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE628113JAN05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE911924MAY05</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</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>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE526904OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL243529</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED INSECT BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEST NILE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P082141</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230205K07BRA</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230005M07SWE</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P084107</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE940107MAR07</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS ^BANYU^</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOCITABINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230052M07FRA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230092M07GBR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN EVOHALER (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230035M07DEU</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07102291</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIAC ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG,DAILY,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL THROMBOSIS LIMB</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP009602</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DURAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG;QW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002005</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007001999</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>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002004</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022731</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB (NATALIZUMAB)</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D /00107901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSU-2007-00800</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN (OLMESARTAN) (20 MILLIGRAM, TABLET) (OLMESARTAN)</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, QD), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM (MELOXICAM) (MELOXICAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGROTON (CHLORTALDONE) (CHLORTALIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027619</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>87942</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027681</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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPENTUM</medicinalproduct>
        <drugauthorizationnumb>19715</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04837</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>72052</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200701378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugauthorizationnumb>13217</drugauthorizationnumb>
        <drugdosagetext>800 MG, BID</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 MCG EVERY 3 DAYS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1-2 EVERY 4 HOURS AS NEEDED</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL                            /00002101/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711USA00542</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>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0605USA02594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARMOUR THYROID TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-MERCK-0706USA00993</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA03497</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>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA03070</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0708USA05854</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>831</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYCARBOPHIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>566</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>759</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA00818</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>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060917</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00019</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>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06121</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>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00017</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>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </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>5507801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA06863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugauthorizationnumb>012649</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASVERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULOBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-MERCK-0710PRT00008</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OVARIAN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0709USA01348</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0709DEU00962</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>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugauthorizationnumb>020180</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA05776</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugauthorizationnumb>18086</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugauthorizationnumb>018086</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0406USA01321</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID MARGIN CRUSTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00288</companynumb>
    <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0702USA04662</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL ALVEOLAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROUS DYSPLASIA OF BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>267</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0709USA03232</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA00823</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURED SACRUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA02302</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>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA02030</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUALLY TRANSMITTED DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA04679</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0707FRA00041</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>21549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</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>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070421</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070421</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SYNOVIAL SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SYNOVIAL SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-13965405</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOLFF-PARKINSON-WHITE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13968870</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>074258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13968946</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN-C</medicinalproduct>
        <drugauthorizationnumb>62336</drugauthorizationnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF RENAL PELVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH200710006507</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710006876</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>0.75 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
        <drugtreatmentduration>367</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON                                 /GFR/</medicinalproduct>
        <drugdosagetext>8 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK</medicinalproduct>
        <drugdosagetext>3 PER 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASTUFER</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSSOFORTIN FORTE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200709005380</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>ANASTOMOTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GALLBLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006930</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200709006742</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALIN                       /00127501/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707003371</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>77.097</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710006128</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR200710007141</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL 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>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710006134</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710006827</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR200710006120</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>16 MG, 3/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200710007309</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-521805</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>96.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REPORTED AS PEGASYS PRE-FILLED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PURDUE-GBR_2007_0003391</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029989</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007EN000250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>21610</drugauthorizationnumb>
        <drugdosagetext>20 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007EN000227</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>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>21610</drugauthorizationnumb>
        <drugdosagetext>10 MG;Q12H</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugdosagetext>5 MG;QD</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007EN000195</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>21610</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029016</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE</medicinalproduct>
        <drugdosagetext>REPORTED AS: BIRTH CONTROL (UNKNOWN TYPE).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17938</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-412370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</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>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473383</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007KW12585</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGODIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
        <drugtreatmentduration>256</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467348</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>54.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP07373</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060425</drugenddate>
        <drugtreatmentduration>371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE303521JUL04</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE103714JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980112</drugenddate>
        <drugtreatmentduration>371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980112</drugenddate>
        <drugtreatmentduration>371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029978</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473391</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYPOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US18058</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>69.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.736</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, Q28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13433</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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0038</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029979</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>159065USA</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE INHALATION, 0.09 MG (SALBUTAMOL)</medicinalproduct>
        <drugauthorizationnumb>21457</drugauthorizationnumb>
        <drugdosagetext>1-2 PUFFS AS NEEDED,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>159067USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE INHALATION, 0.09 MG (SALBUTAMOL)</medicinalproduct>
        <drugauthorizationnumb>21457</drugauthorizationnumb>
        <drugdosagetext>2 PUFFS FOR CONTROL FOR ASTHMA</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINESSA</medicinalproduct>
        <drugbatchnumb>6JM120</drugbatchnumb>
        <drugauthorizationnumb>19697</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071007109</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071004471</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>70.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>75 MG IN AM; 75 MG IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>50 MG IN AM; 75 MG IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00890307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>VARYING DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-527848</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>DOSING AMOUNT: LESS THAN 1 ML. MALADMINISTRATION.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>A SMALL PART OF THE INJECTION GIVEN PARAVENOUSLY.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEPILEPTIC</medicinalproduct>
        <drugdosagetext>DRUG NAME: ANTIEPILEPTICS</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-527592</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS F. C. TABS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS CARDIOVASCULAR AGENT NOS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-524366</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>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE DECREASED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-524088</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-466896</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIXA</medicinalproduct>
        <drugauthorizationnumb>21304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS CHORIORETINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIXA</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060308</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIXA</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIXA</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060725</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060807</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060807</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>GENERIC NAME REPORTED AS SANILVUDINE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060807</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060807</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070218</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: CHEMOTHERAPEUTICS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-479727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060830</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE INCREASED.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092466</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugindication>CEREBRAL CIRCULATORY FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.9MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SV-ROCHE-511116</companynumb>
    <primarysource>
      <reportercountry>EL SALVADOR</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090937</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007090435</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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007072760</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FOLATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDOCILLIN 1200</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007066577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>020779</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2500MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:900MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007046045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugbatchnumb>11038,11120</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugbatchnumb>11038,11120</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079842</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>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006149807</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>FREQ:ONCE OR TWICE PER DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>FREQ:ONCE OR TWICE PER DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006127509</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>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-0712116US</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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>100 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>100 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005412</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A299995</drugbatchnumb>
        <drugindication>MULTIPLE FRACTURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711000004</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYL ICOSAPENTATE</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE DUCT STONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1.5 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHAJINKIGAN</medicinalproduct>
        <drugdosagetext>5 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060609</drugenddate>
        <drugtreatmentduration>389</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200709003452</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</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>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLELITHIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSPANON</medicinalproduct>
        <drugdosagetext>240 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLELITHIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>32 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>6 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006129300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006071808</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URAPIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugdosagetext>TEXT:1 DOSE FORM-FREQ:TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2006057955</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>506679</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYDROGEN CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006029545</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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007074021</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <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>FACIAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URISPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007077372</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:450MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:70MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:70MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:450MG-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007079796</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNICORDIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:37.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:7.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUROBIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:5MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOBRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089302</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006143417</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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US248023</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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006143056</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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0422701-00</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>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN PAINKILLERS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507938-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006138026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>TEXT:12.5MG AND 25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0376615-00</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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE949528JAN05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-H00920707</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>^2 MORE OF EFFEXOR^ DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>^2 BLISTER PACKS OF LEXOMIL^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-WYE-H00898907</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020225</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507943-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US250210</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugdosagetext>2.5 MG TOTAL WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-AMGEN-US250515</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>LUNG INFILTRATION MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007080342</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007519</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ON THERAPY FOR 56 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>56 DAYS OF THERAPY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006121177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US235957</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007090776</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-SEALS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US250569</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007011794</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILOPROST</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US239372</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>GOITRE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25MG, FREQUENCY NOT STATED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006150479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US229622</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007003115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071029</receiptdate>
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    <companynumb>IN-BAXTER-2007BH008622</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0705012</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEFOL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOPRON X2</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIA</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEANXIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-JNJFOC-20071007036</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 1/35-21</medicinalproduct>
        <drugauthorizationnumb>17919</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-AMGEN-US250516</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006143510</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008113</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>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REACTION TO FOOD ADDITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>PEM029</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>PEM029</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>GENERAL PHYSICAL CONDITION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
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    <companynumb>ES-ROCHE-346232</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
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        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS VIAL.</drugdosagetext>
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        <drugstartdate>20030403</drugstartdate>
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        <drugenddate>20030602</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>20030403</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
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    </patient>
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    <safetyreportid>5507968-0</safetyreportid>
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      <reportercountry>PORTUGAL</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028023</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT HOME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK, SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249817</companynumb>
    <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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P092041</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13857974</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>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007035149</companynumb>
    <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 COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FORMICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY NOS</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONSTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-US250635</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50MG LYOPHILISED ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50MG PREFILLED ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007037356</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-200600037</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.091</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugbatchnumb>C1270</drugbatchnumb>
        <drugdosagetext>200UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007069696</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-527886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>76264, 77484</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-525557</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HN-ROCHE-527337</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007055183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEOSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX243186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007062479</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US244607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007061294</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-QUU246659</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007058014</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRSOGLADINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-US250731</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006124048</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX250383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5507999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006119890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US241151</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICITRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080691</companynumb>
    <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX250151</companynumb>
    <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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
        <drugindication>CRYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO/OVRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL242688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086299</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423017-00</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>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020632</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGYNON</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007081703</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:24MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US236167</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249955</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249917</companynumb>
    <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 VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007080644</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>65883006</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088458</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>TEXT:2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GENERAL NUTRIENTS/MINERALS/VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087502</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25601</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25471</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007085412</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>TEXT:5MG/40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>TEXT:5MG/40MG: 5MG/40MG-FREQ:FREQUENCY:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT</medicinalproduct>
        <drugdosagetext>TEXT:300MG/12.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMOL</medicinalproduct>
        <drugdosagetext>TEXT:2 PUFFS-FREQ:PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007084232</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008451</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0705015</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPLOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE213620JUL06</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIQUILAR-28</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19190</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOMYOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060703</drugenddate>
        <drugtreatmentduration>664</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00902207</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>^GRADUALLY INCREASED^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>^TAPERED DOWN^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007084168</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPEN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.727</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007087473</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087639</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPRODONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVINE ADENINE DINUCLEOTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007089449</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BARNIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>TEXT:160/25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPLAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-PFIZER INC-2007087388</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAURIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANOPYRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091467</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007091630</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-10977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10992</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091121</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007089622</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID SUSPENSION, ORAL</medicinalproduct>
        <drugauthorizationnumb>21132</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICILLIN</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13968136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEMPRA</medicinalproduct>
        <drugauthorizationnumb>022065</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13940093</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA FOR INJ</medicinalproduct>
        <drugdosagetext>3 DOSAGEFORM = 2 DOSES. EVENT OCCURED AFTER 2-3 INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006042255</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007040665</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVREDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW15969</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007033788</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2006088247</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOIDAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>TEXT:UNKNOWN-FREQ:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2005013837</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>018147</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:20MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOSIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091198</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-030416</companynumb>
    <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>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-SHR-MY-2007-041429</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>63539C</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>100 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-002816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VB3338A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHANECHOL</medicinalproduct>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-041136</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-040608</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-010986</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>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGY TO ANIMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>52341B</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (PAH)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-040573</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-014882</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL CLEFT HAND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-041217</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SHR-IT-2007-040576</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>40 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-024421</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA PRO</medicinalproduct>
        <drugbatchnumb>050872</drugbatchnumb>
        <drugauthorizationnumb>021258</drugauthorizationnumb>
        <drugdosagetext>0.045 / 0.015 MG/D, CONT</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA PRO</medicinalproduct>
        <drugauthorizationnumb>021258</drugauthorizationnumb>
        <drugdosagetext>.045/.015 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007046162</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508079-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-PFIZER INC-2007089930</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZMAX</medicinalproduct>
        <drugauthorizationnumb>050797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRACHEOBRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508080-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:15MG/M2-FREQ:CYCLIC: ON DAYS 1-28, EVERY 42 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007047382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040314</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>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-024662</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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA6021B</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508086-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092296</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>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOMER</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040842</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>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-031270</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8749A/WA8745A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9732A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE W/BENAZEPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^SULFAMETH-EMP^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZID ^HARRIS^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040341</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-038562</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8746A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508092-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.805</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508093-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-09924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
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        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>129</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508094-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091299</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>CS-RANBAXY-2007US-11032</companynumb>
    <primarysource>
      <reportercountry>SERBIA AND MONTENEGRO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>076989</drugauthorizationnumb>
        <drugdosagetext>3.125 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508100-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11109</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>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>065061</drugauthorizationnumb>
        <drugdosagetext>150 MG, TID</drugdosagetext>
        <drugindication>PERIODONTAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN SR</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
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        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
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  <safetyreport>
    <safetyreportid>5508105-9</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071025</receiptdate>
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    <companynumb>US-PFIZER INC-2007070988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>GLAUCOMA</drugindication>
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        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
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  <safetyreport>
    <safetyreportid>5508106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20041122</drugstartdate>
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  <safetyreport>
    <safetyreportid>5508107-2</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedate>20071106</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>96.6</patientweight>
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      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
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        <medicinalproduct>METHADONE HCL</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5508111-4</safetyreportid>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFERCE</medicinalproduct>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007092160</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>SILDENAFIL (PAH)</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTICOAGULANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugindication>HIV WASTING SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-07P-150-0420318-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL ABCUR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIOMAZINE MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076276</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugbatchnumb>6XT035A</drugbatchnumb>
        <drugauthorizationnumb>020329</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW01935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10444</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>70.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100 MG TO 300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
        <drugtreatmentduration>1064</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060914</drugenddate>
        <drugtreatmentduration>1949</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTIMAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001211</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECONAZOLE NITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25185</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>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709001564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>A317725</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL200708003534</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugindication>AUTISM SPECTRUM DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006397</companynumb>
    <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 BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX200710003392</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006398</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>GASTROSTOMY TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006497</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>141.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA200710002177</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>VESTIBULAR ATAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006642</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007075792</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL - SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZADITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200701004650</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20061013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG, 3/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003801</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ELI_LILLY_AND_COMPANY-AR200710006610</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>BLOOD BILIRUBIN UNCONJUGATED 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>20070101</drugstartdate>
      </drug>
      <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>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007071524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RESPIRATORY DISTRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>N53568</drugbatchnumb>
        <drugdosagetext>0.6 UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINOLONE ACETONIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR OINTMENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074830</companynumb>
    <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-PFIZER INC-2007083787</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.469</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>7.5 MG/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007083415</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESITRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007082995</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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>TEXT:1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:75MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PASIL</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PASIL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>TEXT:2 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.5GRAM-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPA</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007082838</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COKENZEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092142</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508147-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422626-00</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>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508148-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-249748</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, Q4W</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007087196</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTROCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (NEEDS NO REFRIGERATION)</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007086874</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>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-PFIZER INC-2007085242</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROTALCITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENALOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086025</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/KG, Q2W</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>5000 MG, CONTINUOUS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508157-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.9</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
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        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5508158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090113</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>ASPERGILLOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugindication>ASPERGILLOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>ASPERGILLOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GENENTECH-216059</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 MG/KG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINFLUNINE</medicinalproduct>
        <drugdosagetext>550 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINFLUNINE</medicinalproduct>
        <drugdosagetext>280 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007090076</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200711459</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508165-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711749</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>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>780</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508166-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200605757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>1171-10</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508167-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508168-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-PFIZER INC-2007088709</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRANIOPHARYNGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0</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>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>75/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>81 MG 2 TABLETS Q.D.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-A06200700065</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE ACHOLURIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
        <drugtreatmentduration>352</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-SANOFI-SYNTHELABO-D01200701449</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL HYPOGLYCEMICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY FOR 2 WEEKS FOLLOWING BY 300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200700824</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705806</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007088346</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706185</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>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-231549</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.2 MG, TID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.75 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007187</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA200710003170</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006688</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007087966</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.4MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MCG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.4MG-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200700210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090257</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090251</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HCL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711414</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712331</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706186</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>5 OR 10 MG DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423195-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418668-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</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>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ABBOTT-07P-135-0423032-00</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090383</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090274</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:300MG-FREQ:EVERY DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090453</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugindication>EMPYEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXPECTORANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090940</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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090938</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2007090651</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007090760</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPANUTIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-PFIZER INC-2007090642</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-PFIZER INC-2007090630</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPHAEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090592</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090484</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007090519</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0422719-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ABBOTT-07P-135-0423030-00</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091397</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INCOMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPROLACTINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091396</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2007091020</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090946</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007092522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GILEAD-E2B_00000010</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508234-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GENENTECH-250665</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>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091886</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646222A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508241-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648361A</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>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649102A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VAGINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669495A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677100A</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654730A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>050754</drugauthorizationnumb>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>062216</drugauthorizationnumb>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664691A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>50760</drugauthorizationnumb>
        <drugdosagetext>5CC TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642863A</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>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>062216</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091767</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</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>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643629A</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>21.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>062226</drugauthorizationnumb>
        <drugdosagetext>30CC TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644294A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>62226</drugauthorizationnumb>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941130</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645965A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>062226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050575</drugauthorizationnumb>
        <drugdosagetext>1.5TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650470A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>062226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugbatchnumb>T60007</drugbatchnumb>
        <drugauthorizationnumb>050575</drugauthorizationnumb>
        <drugdosagetext>.5TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651078A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>062226</drugauthorizationnumb>
        <drugdosagetext>1TSP THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651310A</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>
      <patientweight>20.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>T600L7</drugbatchnumb>
        <drugauthorizationnumb>062226</drugauthorizationnumb>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2006-BP-11959RO</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS TRANSITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TABLETS USP, 20MG</medicinalproduct>
        <drugauthorizationnumb>87342</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMYELINATING POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>1% (50 MG) TO SKIN DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1 MG IM WEEKLY ON MONDAYS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5 MG QHS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250425</companynumb>
    <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091770</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007091719</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL CAP</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.5MG-FREQ:FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMOTIONAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROLIXIN DECANOATE</medicinalproduct>
        <drugdosagetext>TEXT:1 INJECTION Q MONTH</drugdosagetext>
        <drugindication>EMOTIONAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugbatchnumb>200657</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2002-BP-03777BP</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22786PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22859PF</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>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23408BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22904BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508265-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23252NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugauthorizationnumb>12836</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23238BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23090YA</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19199BP</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>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22813BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23098NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23241BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23463BP</companynumb>
    <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</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>5508273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06417GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugauthorizationnumb>021814</drugauthorizationnumb>
        <drugdosagetext>TIPRANAVIR 1000 MG/RITONAVIR 400 MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20525BP</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609989B,7C1206</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609989B,7C1206</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>DYSPNOEA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19794BP</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>J0600423</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLUDROCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508277-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-CN-00761CN</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>019085</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22922PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703786A,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23008BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508280-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21138BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>508689B,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18718BP</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>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>NOCTURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23878PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugindication>NASAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23867YA</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAXTRA XL (TAMSULOSIN) ORODISPERSABLE CR TABLET 0.4MG</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18623BP</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665101A,765042A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19850PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702151A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-06447BP</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>608032</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22818BP</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20099BP</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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765039A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23406BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19892BP</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>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23665BP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22996BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19608BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702140A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702140A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19841BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>2009751A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>BRACHYTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22755NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22719BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23736NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23019BP</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704894A,7C2205</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23038BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704577A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22138BP</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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22736BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07005BP</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>509935</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-07875BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>510176,4C1208</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-10003BP</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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>602274A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-13093BP</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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>603258,5C1216,604005A,4C2205</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23138BP</companynumb>
    <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>RESIDUAL URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-14280BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>605863B,5C1220</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508308-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23059BP</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>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-09052BP</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0613759,0613761,613757</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508310-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22713BP</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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702049A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508311-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22712BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPRIADAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508312-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22710BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508313-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22803BP</companynumb>
    <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22669BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0604491</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508315-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22667BP</companynumb>
    <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 RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508316-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22364BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METACAM ORAL SUSPENSION</medicinalproduct>
        <drugbatchnumb>NOT  REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21530</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22625BP</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</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>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22609BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE NASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugindication>INTRAOCULAR PRESSURE TEST ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22715BP</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A26787</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A26787</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22629BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20841BP</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704176A,7C3201</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23848BP</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugdosagetext>TEXT:22 UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRAL INSULIN INJECTION</medicinalproduct>
        <drugdosagetext>TEXT:104 UNITS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091542</companynumb>
    <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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091619</companynumb>
    <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>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE271021SEP07</companynumb>
    <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>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LORDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086301</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086301</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugauthorizationnumb>018922</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091541</companynumb>
    <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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091426</companynumb>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-250004</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>50018</drugbatchnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYLLOCONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508332-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:225MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>020682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:225MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>020682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>020682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:75MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090985</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050162</drugauthorizationnumb>
        <drugindication>ENDOCARDITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1500MG</drugdosagetext>
        <drugindication>ENDOCARDITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0378413-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS-RESISTANT LACTIC ACID BACTERIAE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508335-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ABBOTT-07P-055-0422231-00</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOGRAPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OCULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N52713</drugbatchnumb>
        <drugdosagetext>1.25 MG, Q2M</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugdosagetext>UNK GTT, QID X4 DAYS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE538525OCT06</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0418536-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE DE SODIUM WINTHROP LP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-07P-143-0422699-00</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50698</drugauthorizationnumb>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422549-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423018-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GENENTECH-224128</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>65 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N52713</drugbatchnumb>
        <drugdosagetext>1.25 MG, Q2M</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAIN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508344-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE992912APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRALATERAL BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-248819</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B3138, B3070</drugbatchnumb>
        <drugdosagetext>870 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508346-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250378</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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N64836</drugbatchnumb>
        <drugdosagetext>590 MG, DAYS 1+15</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>7 MG, UNK</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00978307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>TORISEL</medicinalproduct>
        <drugbatchnumb>P00004AA</drugbatchnumb>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247249</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>
      <patientweight>51.247</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>98.4 MG/M2, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>3.4 AUC, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5508350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00024</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPTIC ISCHAEMIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5508351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00010</companynumb>
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      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
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        <drugenddate>20071005</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
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  <safetyreport>
    <safetyreportid>5508352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
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        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
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        <drugenddate>20070101</drugenddate>
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        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>5508353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>NEW ZEALAND</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
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        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030923</drugenddate>
        <drugtreatmentduration>832</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031023</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
        <drugtreatmentduration>833</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-MERCK-0711HUN00001</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0711NZL00004</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00548</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGSIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0711NZL00002</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508360-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00014</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0711SWE00003</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STERCULIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508362-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0710DEU00373</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>21995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508363-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00007</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</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>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SPASTIC PARAPLEGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE CONTRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPTAMINOL ADENYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508364-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0711NZL00003</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508365-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0710NZL00007</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA04705</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508367-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0707USA03075</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508368-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00011</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508369-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071102</receiptdate>
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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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508370-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071022</receiptdate>
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    <companynumb>DE-GENENTECH-249684</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.011</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>825 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5508371-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071025</receiptdate>
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    <companynumb>US-GENENTECH-247771</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>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N52713</drugbatchnumb>
        <drugdosagetext>1.25 MG, Q2M</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugdosagetext>UNK, X2</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugdosagetext>UNK, QID</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>5508372-1</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071025</receiptdate>
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    <companynumb>US-GENENTECH-248896</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>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N67150</drugbatchnumb>
        <drugdosagetext>UNK, Q2M</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>UNK, Q12H</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508373-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.039</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB REDUCTION DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>M92082</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>P538202, 1848001</drugbatchnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508374-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-248691</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSCALCULIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508375-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-222051</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>780 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
        <drugtreatmentduration>142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1300 MG, UNK</drugdosagetext>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508376-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008152-07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508377-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008478-07</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508378-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DK04175</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG OR 90 MG EVERY FOUR WEEKS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060818</drugenddate>
        <drugtreatmentduration>491</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007TR06553</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.702</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</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>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <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>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>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508381-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FI17979</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03639</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOX</medicinalproduct>
        <drugauthorizationnumb>21285</drugauthorizationnumb>
        <drugdosagetext>3150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02167</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508384-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IN18379</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>GRAFT THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508385-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US18365</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>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE 2%  (NVO)</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>MIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508386-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02044</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, EVERY 3 TO 4 WEEKS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508387-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX18119</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160/12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508388-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2005AU00655</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugdosagetext>OCCASIONAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>VERY OCCASIONALLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508389-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US14887</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001 VS PLACEBO</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001 VS PLACEBO</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugindication>CARCINOID TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IE14404</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US07517</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>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>0.75 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007RU18343</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>6 TABLETS/DAY</drugdosagetext>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03183</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>928</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03227</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508395-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GB18282</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LASER THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugauthorizationnumb>011838</drugauthorizationnumb>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZEPAM</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOACTIVE IODINE TREATMENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508396-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03625</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>90 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508397-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18292</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugbatchnumb>Z0058</drugbatchnumb>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLAVONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMICIFUGA RACEMOSA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508398-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AT13118</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBO ASS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-D-VITA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508399-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US07212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.319</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508400-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP18120</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508401-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>011793</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US15042</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>42.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>1750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOSIDEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugindication>HAEMOSIDEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508403-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15362</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508404-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11536</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0009</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>318</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2006AU00878</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTODERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE18014</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>70.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>301</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03315</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>64.852</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOMPHALOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US03628</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>65.759</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST COSMETIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST RECONSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MODIFIED RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLINT APPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>UNK BIW</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625/2.5MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>10MG BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>SOCIAL PHOBIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07334</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG Q4 WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060317</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugdosagetext>1000 MG/M2 WEEKLY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugdosagetext>10 UNK, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.05 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>100 UG, 4 PATCHES Q72H TO SKIN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>40,000 UNITS, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^WYETH-AYERST^</medicinalproduct>
        <drugdosagetext>25 MG, Q6H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508410-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US05719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.458</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE + ADRIAMYCIN + DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 MCG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508411-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>THROMBOSIS IN DEVICE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508412-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071006623</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPISOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPISOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00549307</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>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00545107</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS (600 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZANIL</medicinalproduct>
        <drugdosagetext>4 TABLETS (24 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE474414SEP05</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>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE WHITENING PRE-BRUSH RINSE (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>01417C</drugbatchnumb>
        <drugdosagetext>3 TEASPOON ONCE A DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.98</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BELLIGERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS AT 9.05PM AND 9.56PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEMISODIUM VALPROATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071007002</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>2ND CYCLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>2ND CYCLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100074</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>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007088</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007084</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007069</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508447-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070903484</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>6FLIG00</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>6FLIG00</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508448-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007843</companynumb>
    <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 TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708391</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708391</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007867</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>07077961</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>07077961</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007952</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0633869</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</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>
        <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>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>HALF AN 800MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>TAKEN SINCE THE 1990S</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007069</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007081</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508455-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007084</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508456-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-JNJFOC-20071007088</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508457-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007985</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugauthorizationnumb>020897</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508458-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE165302JUN04</companynumb>
    <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 FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508459-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE240919JUL04</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE217403NOV04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <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>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AU18016</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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1040 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14365</companynumb>
    <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>RENAL STONE REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR02881</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007HK13961</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELBIVUDINE (LDT)</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>629</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>600 UG Q3HR BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>600 UG Q3HR BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugdosagetext>600 UG TID BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugdosagetext>600 UG TID BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>125 UG Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>125 UG Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 UG WEANING DOSAGE IN ANTICIPATION OF DISCONTINUATION Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 UG WEANING DOSAGE IN ANTICIPATION OF DISCONTINUATION Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 UG Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 UG Q1HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON /01487002/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KADN20070091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133.1307</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugdosagetext>1 CAP DAILY, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-500</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
        <drugauthorizationnumb>17768</drugauthorizationnumb>
        <drugdosagetext>TOPICAL 060</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007665</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 NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>9 INFUSIONS ON UNSPECIFIED DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071007996</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070705116</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20061202481</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN RESPIRATORY TRACT NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE658730JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA MYCOPLASMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIMIDE</medicinalproduct>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021047</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>6-CO-4003</drugbatchnumb>
        <drugdosagetext>30 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugbatchnumb>6RCJ037</drugbatchnumb>
        <drugdosagetext>600 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P092190</drugbatchnumb>
        <drugdosagetext>40000 IU; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUALAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021912</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>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2; ; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10 MG/KG; ; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30809_2007</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>BONE MARROW TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508510-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021864</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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020011</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>78.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>140 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021871</companynumb>
    <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP017312</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>100 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>100 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020014</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>86.637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1200 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021955</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>140 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711000686</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALIN                       /00127501/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020299</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>64 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>A21331</drugbatchnumb>
        <drugdosagetext>400 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL /00091301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN /00450801/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE /00724402/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C /00008001/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508524-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021880</companynumb>
    <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508527-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021793</companynumb>
    <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>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508529-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE569822APR04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508530-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE810813APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE440625JUL05</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>CONTRALATERAL BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE426626JUL04</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAGET'S DISEASE OF NIPPLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE134827OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>6.25MG/2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021867</companynumb>
    <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-1164406</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugdosagetext>4 GTT ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713583BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>100</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN RELIEVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-165935-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESMOLOL HCL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE W/ EPINEPHRINE</medicinalproduct>
        <drugdosagetext>0.9 ML ONCE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11950</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVATRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISODIUM VALPROATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007090024</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugauthorizationnumb>20114</drugauthorizationnumb>
        <drugdosagetext>1096 MCG (548 MCG, 2 IN 1 D), IN</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugauthorizationnumb>20114</drugauthorizationnumb>
        <drugdosagetext>1096 MCG (548 MCG, 2 IN 1 D), IN</drugdosagetext>
        <drugindication>VASOMOTOR RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30823_2007</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA (TEMESTA - LORAZEPAM) (0.5 MG, ) (NOT SPECIFIED)</medicinalproduct>
        <drugbatchnumb>C10434</drugbatchnumb>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(0.5 MG QD ORAL, (0.5 MG QD DIFFERENT LOT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA (TEMESTA - LORAZEPAM) (0.5 MG, ) (NOT SPECIFIED)</medicinalproduct>
        <drugbatchnumb>C10434</drugbatchnumb>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(0.5 MG QD ORAL, (0.5 MG QD DIFFERENT LOT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE711703AUG04</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2006-13179</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL, 100 MG, TID, ORAL, 200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIEMANN-PICK DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL, 100 MG, TID, ORAL, 200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIEMANN-PICK DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL, 100 MG, TID, ORAL, 200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIEMANN-PICK DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18225</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN TABLET 62.5 MG EU(BOSENTAN TABLET 62.5 MG EU)  BOSENTAN TABLE</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGUS CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070802773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-15460103</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO HEART</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABBOKINASE</medicinalproduct>
        <drugauthorizationnumb>21846</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASCULAR OCCLUSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508566-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163516ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74656</drugauthorizationnumb>
        <drugdosagetext>(144 MG, 1 IN 21 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PF-3512676</medicinalproduct>
        <drugdosagetext>(15.2 MG, ON DAY 8 AND 15 OF 21 DAYS CYCLE), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070122</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2400 MG (2400 MG, DAY 1 AND 8 OF 21 DAY CYCLE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713364BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 0.125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMIN CHONDROITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEN'S HEALTH VITAMINS/MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616063GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE CREAM 1.%</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25424</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508577-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-06-0512</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-268920</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>TP51348</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTALIP</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508585-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-265382</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>90 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRYOPRECIPITATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-265371</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>90 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRYOPRECIPITATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508587-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-267099</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>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20741</drugauthorizationnumb>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                           /00002703/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC                            /00003301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM                            /01479302/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN                             /00880402/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-NOVOPROD-268771</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>14.4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>6.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBONDRIN</medicinalproduct>
        <drugdosagetext>1 VIAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUDACORTIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PPI                                /00661201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APREDNISLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN                            /00021101/</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-268006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>90 IU, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508590-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03261</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508591-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03705</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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTOPIDIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508592-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716563GDS</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEURSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508593-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716522GDS</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>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SANDOZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXAGON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCANTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508594-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-269012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508595-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-269013</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>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>1211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HCL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508596-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-NOVOPROD-269003</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>12 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>36 U, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOMET                           /00082701/</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMICHEK</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORLIP</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508597-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE812615OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508598-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710180BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508601-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022039</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>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508602-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020739</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD;PO;  600 MG;QD; PO;  400 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD;PO;  600 MG;QD; PO;  400 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD;PO;  600 MG;QD; PO;  400 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508603-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021842</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>400 MG;BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A (PEGINTERFERON ALFA-2A)</medicinalproduct>
        <drugdosagetext>180 MCG; QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508608-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13969654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13968417</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOPHOS FOR INJ 100 MG</medicinalproduct>
        <drugauthorizationnumb>20457</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508610-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710703BYL</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRYPSIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAY43-9006</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAY43-9006</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 3 MG  UNIT DOSE: 3 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 12 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 4 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 600 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLELITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 25 MG  UNIT DOSE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 5 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASPORT</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 40 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEFANIL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 300 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCOBA</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CATARACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 40 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-VG</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERATINAMIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.1</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICARBONATED RINGER'S SOLUTION</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 500 ML</drugdosagetext>
        <drugadministrationroute>011</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 500 ML  UNIT DOSE: 500 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 300 MG  UNIT DOSE: 300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 2 G  UNIT DOSE: 1 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>C-REACTIVE PROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 25 MG  UNIT DOSE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508612-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13970033</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS LEUKOPENIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL INJ 6 MG/ML</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508613-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13960497</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>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECALL PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugdosagetext>8-WEEK CYCLES OF PACLITAXEL 80 MG/M SUP(2), WEEKLY PACLITAXEL 50MG/M SUP(2)</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508614-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13971155</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508615-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13969456</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN DECANOATE</medicinalproduct>
        <drugauthorizationnumb>016727</drugauthorizationnumb>
        <drugdosagetext>1DOSAGEFORM=1 INJECTION.</drugdosagetext>
        <drugindication>EMOTIONAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1DOSAGE FORM=1TABLET(0.5MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMOTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508616-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13965314</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN-C</medicinalproduct>
        <drugauthorizationnumb>62336</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508617-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13965280</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN-C</medicinalproduct>
        <drugauthorizationnumb>62336</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HCL</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13848163</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508619-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13967914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-13960380</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13874300</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13939814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>018207</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugdosagetext>DOSE 1 CAPSULE(30 MG) DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508623-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13946603</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREVIBLOC</medicinalproduct>
        <drugauthorizationnumb>19386</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>025</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE W/ EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>025</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>025</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508624-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13966155</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREMIFENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISODIUM INCADRONATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30813_2007</companynumb>
    <primarysource>
      <reportercountry>AFGHANISTAN</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>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>60 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE812015OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071007747</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070704211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100723</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <receiptdate>20071029</receiptdate>
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    <companynumb>CA-NOVOPROD-262913</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERX SOLUTION 2.6 MG/STRIP</medicinalproduct>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERX SOLUTION 2.6 MG/STRIP</medicinalproduct>
        <drugdosagetext>8 IU, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugbatchnumb>SP50015</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>13 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>19 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00831701/</medicinalproduct>
        <drugdosagetext>1 CAPS, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508631-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-BAYER-200716569GDS</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019847</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200711142BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 4 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HUDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 450 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 18 ?G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 800 ?G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZACHEW MELTDOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508633-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200710784BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA ANNULARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508634-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712004BWH</companynumb>
    <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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508635-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-200716374GDS</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>IIIRD NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508636-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710810BYL</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713039BWH</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>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508638-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712740BWH</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713060BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713384BWH</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713076BWH</companynumb>
    <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>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713117BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508643-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711199BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712949BWH</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>BXC1W91</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508646-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK249984</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-AMGEN-UK250805</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-WYE-H00703507</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>21919</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>21919</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
        <drugdosagetext>10 (UNITS NOT PROVIDED), TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-US251212</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508654-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-UK239920</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK241528</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>N1220AA,D1356AF,N1356AF,1000013</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-US251219</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508657-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020439</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPROSTENE (BETAMETHASONE SODIUM PHOSPHATE/DIPROPIONATE) (BETAMETHASON</medicinalproduct>
        <drugauthorizationnumb>14602</drugauthorizationnumb>
        <drugdosagetext>7 MG; ONCE; IA</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP010226</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>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WAKOBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK203853</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 TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIFERMIN</medicinalproduct>
        <drugauthorizationnumb>6370</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK240854</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugbatchnumb>D078283,D065690,D065689,D085994,D06</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02137</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugbatchnumb>001D58</drugbatchnumb>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30810_2007</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>120 MG QD ORAL;  A FEW YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CARDIOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508664-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU242651</companynumb>
    <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086297</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086297</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE AQUA</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVONEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508665-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX248659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086320</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086320</drugbatchnumb>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU246480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <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>MOBIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250230</companynumb>
    <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>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095193</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095193</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250272</companynumb>
    <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 HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P078157</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORASTAT PLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORASTAT PLUS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508675-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713431FR</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>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200715136EU</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200715135EU</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugauthorizationnumb>018538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712934JP</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AVENTIS-200720101GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>17922</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-COMPLEX, INCL COMBINATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720072GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0423362-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </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>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14396</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508690-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14412</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249964</companynumb>
    <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>SENSIPAR</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00474</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COITAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARMONY WOMENA??S PRE-MENSTRUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNER HEALTH PLUS DAIRY FREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14407</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508694-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14329</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10096</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-UK243415</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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 PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK250025</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508702-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK235529</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIMPARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPAKE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249968</companynumb>
    <primarysource>
      <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>CALCIPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENALTABS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250705</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 ML, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATION NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE184418MAR05</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2004P0909</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050330</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>P.R.N.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>100 MG (ONE DOSE ADMINISTERED UNTIL NOW)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.2878</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE TOOTH DEFENSE (SODIUM FLUORIDE)</medicinalproduct>
        <drugbatchnumb>00517L</drugbatchnumb>
        <drugdosagetext>1 TEASPOON 1 TIME A DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL FLUORIDE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP06391</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14969</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugindication>REFLUX GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGYNON</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508712-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25396</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDANTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALEATO DE ENALAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ASTRAZENECA-2007SE05783</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508714-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06920</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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250690</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 MG/KG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007330203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE TOOTH DEFENSE (SODIUM FLUORIDE)</medicinalproduct>
        <drugdosagetext>1 CAPFUL, EVERY MORNING, FOR 4 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007332591</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>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE BUBBLE BLAST (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>00566L</drugbatchnumb>
        <drugdosagetext>10 ML 1 TIME PER DAY (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-165773-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PUREGON</medicinalproduct>
        <drugauthorizationnumb>21057</drugauthorizationnumb>
        <drugdosagetext>450 IU DAILY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORGALUTRAN</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPIN</medicinalproduct>
        <drugdosagetext>10000 IU ONCE SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVULATION INDUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugindication>IN VITRO FERTILISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOPUR</medicinalproduct>
        <drugdosagetext>75 IU DAILY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022835</companynumb>
    <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>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022667</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508722-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI014401</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM; 30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM; 30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508723-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508724-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692025A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBROX DROPS</medicinalproduct>
        <drugbatchnumb>7C3009</drugbatchnumb>
        <drugadministrationroute>001</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508725-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06595</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508726-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EG-ASTRAZENECA-2006SE00437</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1008</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBRAL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 2 PILLS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOVIT B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007SE00268</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIAS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019146</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI018675</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35084</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508732-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508733-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508735-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020532</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022904</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>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG,QM,IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022629</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>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022491</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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV; 300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019897</companynumb>
    <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>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021364</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVORCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020416</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>85.2762</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CVT-062418</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>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</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>RANEXA</medicinalproduct>
        <drugauthorizationnumb>21526</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2007-17224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL; 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL; 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL (LISINOPRIL DIHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM (CHROMIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE (FERROUS GLUCONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL,</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN (INSULIN HUMAN INJECTION, ISOPHANE, INSULIN HUMAN ZINC SUSPENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (FUROSEMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0651995A</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>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0651995B</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 INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0656856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIOVENOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICOURETERIC REFLUX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAOPECTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICK VAPORUB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688332A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688720A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690597A</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691027A</companynumb>
    <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>PREGNANCY ON CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691235A</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691259A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>7ZP6703</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691263A</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R284849</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691265A</companynumb>
    <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>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBICIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692297A</companynumb>
    <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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692302A</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>31.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692310A</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>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>70020</drugbatchnumb>
        <drugauthorizationnumb>20121</drugauthorizationnumb>
        <drugdosagetext>4SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692316A</companynumb>
    <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>INJURY</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>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692320A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508767-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359419A</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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359420A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0483061A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486550A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>BF6363</drugbatchnumb>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488510A</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPATABS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2007-15949</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>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS (COLECALCIFEROL, MANGANESE, CALCIUM, MAGNESIUM, ZINC, CO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488812A</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>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN C DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASENAZOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508774-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489547A</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>CHORIORETINAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHI E NATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANKARU</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490114A</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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491147A</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>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491366A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugauthorizationnumb>017920</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXATOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>330MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491450A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>.8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492446A</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>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492626A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSPOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492627A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LULLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492666A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY GAS EXCHANGE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>50542</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLLOIDAL PLASMA EXPANDER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPROSTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493223A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>1INJ PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABACET</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493724A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493775A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494126A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC ADENOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494172A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVORANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLUVEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494260A</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ADRENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MGML PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494261A</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ADRENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MGML PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494300A</companynumb>
    <primarysource>
      <reportercountry>BOTSWANA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>4.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>4MGK SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>6MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>200MG SEE DOSAGE TEXT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494330A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494337A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2007-14647</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>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020218</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>MEDROXYPROGESTERONE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020250</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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002050</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>(150 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074206</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020882</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>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CHAPPED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP015711</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018553</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>71.6683</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021872</companynumb>
    <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>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FVIIA     NOVO NORDISK</medicinalproduct>
        <drugdosagetext>90 U/KG APPROX X1 IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO FACTOR 7</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERCULIN 5 TU/0.1 ML</medicinalproduct>
        <drugbatchnumb>37258</drugbatchnumb>
        <drugdosagetext>0.1 ML</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C2679AC</drugbatchnumb>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICE BCG</medicinalproduct>
        <drugbatchnumb>451665</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS A, C, AND E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEAXANTHIN MINERALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TB TINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508810-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071007807</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>150 MG X 6 DOSES</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900613</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508812-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5.44</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCENTRATED INFANTS TYLENOL PLUS COLD + COUGH CHERRY</medicinalproduct>
        <drugdosagetext>2 DROPS ONCE</drugdosagetext>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101416</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>
      <patientweight>56.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070604766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0621442</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugdosagetext>1 OR 2 AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NONSPECIFIC REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007834</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>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0529144</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0529144</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0529144</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ISCHAEMIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071004881</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071000382</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD MAGNESIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070705003</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL DECANOAS</medicinalproduct>
        <drugauthorizationnumb>18701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071100260</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>22106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101074</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>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101570</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>1 TWICE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM COLD REMEDY MATRIXX</medicinalproduct>
        <drugbatchnumb>B60526</drugbatchnumb>
        <drugdosagetext>NASAL SPRAY ONCE</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508826-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAVOL HERNIA MESH 4X6 AND 8X10 PIECES DAVOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508829-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.151</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION XL   300 MG   TEVA</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070901456</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA RETARD</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508831-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071007714</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100160</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</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>5508833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100304</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>18.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</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>5508834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100688</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>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508835-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</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>5508836-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20071003993</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071008173</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOSEC</medicinalproduct>
        <drugauthorizationnumb>17694</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRONE+ISOMETHEPTENE+CAFFEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTRO AMPHETAMINE SULFATE TAB</medicinalproduct>
        <drugdosagetext>ONE TAB   TID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugbatchnumb>53555LL</drugbatchnumb>
        <drugdosagetext>25MG/25ML ONCE IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>ONE TABLET  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>27.2158</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>TZF0174</drugbatchnumb>
        <drugdosagetext>VARIES PER INTAKE  MEAL TIMES  SQ LIFETIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE238319JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070902872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEQUAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071100547</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100933</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AVENTIS-200719944GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST                            /01314201/</medicinalproduct>
        <drugauthorizationnumb>20872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEMASTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720105GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFINAH</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>61884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717718US</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: 1 DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508855-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AVENTIS-200719871GDDC</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200513491US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.27</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK; FREQUENCY: EVERY 6 TO 8 HOURS</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK; FREQUENCY: EVERY 6 TO 8 HOURS</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODIPINE/BENAZEPRIL</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-AVENTIS-200720157GDDC</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AVENTIS-200720140GDDC</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN 24</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508861-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION   150MG ER -W-    EON LABS/BIOSCRIP</medicinalproduct>
        <drugbatchnumb>092-000102</drugbatchnumb>
        <drugdosagetext>150 MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG  2X PER DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE ER</medicinalproduct>
        <drugauthorizationnumb>21692</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL HCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100554</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>66.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMACET</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYTOL HERBAL UNWIND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE EXTENDED RELEASE</medicinalproduct>
        <drugbatchnumb>74287</drugbatchnumb>
        <drugdosagetext>100MG XL DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>2 PUFFS AS NEEDED INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEBARAL (GENERIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL (GENERIC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>150 MG PO QDAY</drugdosagetext>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>0.5 - 1TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>0.5 - 1TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUD MIGRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>71682A</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.6079</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANIMAS 2020 INSULIN INFUSION PUMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508890-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE817015OCT04</companynumb>
    <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>20527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007MX18206</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14329</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10096</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007FI16692</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTELOS</medicinalproduct>
        <drugdosagetext>2 G/DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTOL</medicinalproduct>
        <drugdosagetext>200 TO 800 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508895-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA NOS</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>5508896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-519560</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508897-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-430213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0422834-00</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ROCHE-528395</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN OR PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-526273</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>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508909-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-522346</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>019979</drugauthorizationnumb>
        <drugdosagetext>OTHER INDICATION: ANGINA PECTORIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>OTHER INDICATION: CEREBRAL INFARCTION</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALASENN</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENONE</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-481141</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>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY PER PROTOCOL REPORTED AS TWICE PER DAY ON DAY 1 TO DAY 14 EVERY 3 WEEKS. ACTUAL DOSE WAS +</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20071008075</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOMIDATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 50/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0363619-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>PUFF (ROUTE)</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-WYE-G00558407</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25588</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508945-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25409</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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    <companynumb>FR-MERCK-0710FRA00094</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508954-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA04691</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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508955-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA03628</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>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0610USA08479</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA04848</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA03905</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>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508960-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA01327</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>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMINENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0706DEU00081</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>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSTEC</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508962-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA01474</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508964-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0708USA01376</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>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>20387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOLANTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORSENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRESSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706191</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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706228</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UA-SANOFI-SYNTHELABO-D01200703849</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IVABRADINUM</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SL650472</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070602</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705873</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</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>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706182</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>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SANOFI-SYNTHELABO-F01200700360</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON  HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 FOR 2 WEEKS, Q3W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200701291</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>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugdosagetext>100 MG- 650 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022427</companynumb>
    <primarysource>
      <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>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE16588</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CO17231</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>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200701374</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugdosagetext>18 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>50MG/75 MG : BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>50MG/75 MG : BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712477</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugdosagetext>175 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN IN BOLUS THEN 1750MG/BODY AS CONTINUOUS INFUSION ON DAY 1 AND 2</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508993-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712140</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMOSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US08485</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>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</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>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041221</drugenddate>
        <drugtreatmentduration>425</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031024</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030708</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030708</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG, IVP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>680 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508995-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200709735</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-SYNTHELABO-A01200710269</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL ABZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRANDY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <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>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160 / 12.5 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5508999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200701371</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMIN</medicinalproduct>
        <drugdosagetext>4500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINLAXER</medicinalproduct>
        <drugdosagetext>2250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712162</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711322</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICK SINUS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC PACEMAKER INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIBENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECALMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000474</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</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>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21438</drugauthorizationnumb>
        <drugdosagetext>20 MG; Q8H; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugbatchnumb>M200E</drugbatchnumb>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugdosagetext>18 ML (8 ML LEFT ARM, 10 ML RIGHT ARM), SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701252</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>40517</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1-2 TABLET, Q6HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>040517</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CP-751,871</medicinalproduct>
        <drugdosagetext>1560 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CP-751,871</medicinalproduct>
        <drugdosagetext>1600 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CP-751,871</medicinalproduct>
        <drugdosagetext>1540 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>395 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>382 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>329 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>620 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>564 MG, SINGLE ( 1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>516 MG, SINGLE (1 DOSE Q 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN                             /00041901/</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>1 TABLET, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>2 (300 MG, TID)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, ONE TO TWO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PURDUE-MAG_2007_0000601</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>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>3 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>3 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>15 GRAM, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0030032</companynumb>
    <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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03394</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>0</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN(MELPHALAN) VIAL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC (LEVOFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03347</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03182</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>40.00 MG, ORAL, 0.50 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>40.00 MG, ORAL, 0.50 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN (PROCHLORPERAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZA EXTRACT (GLYCYRRHIZA EXTRACT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN (LAFUTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509014-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971437</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13969563</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>86358</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEMPHIGOID</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-BRISTOL-MYERS SQUIBB COMPANY-13971833</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>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS MESENTERIC VESSEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: ALIMTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13967187</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>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>START DATE OF FIRST COURSE: 18-SEP-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>START DATE OF FIRST COURSE: 18-SEP-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>22 DOSAGE FORM = 22 FRACTIONS. TOTAL DOSE: 4400 CGY. START DATE OF FIRST COURSE : 18-SEP-2007</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13929195</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>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>INITIATED 12 WEEKS PRIOR TO THE FIRST DOSE OF BLINDED STUDY THERAPY AND WAS ONGOING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5MGSID ABOUT 56DAYS PRIOR TO ENROLLMENT-22JUN07;5MGSTD 06-JUN07-03OCT07</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>START: ABOUT 56 DAYS PRIOR TO ENROLLMENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugdosagetext>PRIOR TO OBTAINING INFORMED CONSENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13969274</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugauthorizationnumb>016885</drugauthorizationnumb>
        <drugdosagetext>MITOTANE STARTED IN APR-2007, LAST (6TH) COURSE STARTED FROM 17-SEP-2007 TO 20-SEP-2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>STARTED ON 25-JUL-2007; LAST (6TH) COURSE STARTED FROM 17-SEP-2007 TO 20-SEP-2007; DURATION: 57 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugdosagetext>STARTED ON 23-JUL-2007; LAST (6TH) COURSE STARTED FROM 17-SEP-2007 TO 20-SEP-2007; DURATION: 56 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugdosagetext>STARTED ON 24-JUL-2007; LAST (6TH) COURSE STARTED FROM 17-SEP-2007 TO 20-SEP-2007; DURATION: 58 DAY</drugdosagetext>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13966577</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13968441</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>STOP DATE: 26OCT07</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>STOP DATE: 5OCT07</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13956735</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 MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugdosagetext>1.8GM 2/1DAY FROM 14/SEP/2006-27/SEP/2006</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROLEPTAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugauthorizationnumb>018654</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-01335</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100.00 MG, ORALQ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>100.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-01089</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVISCOSITY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE (VELCADE) VELCADE (BORTEZOMIB) INJECTION</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROMIDEPSIN(DEPSIPEPTIDE) POWDER (EXCEPT [DPO])</medicinalproduct>
        <drugdosagetext>21.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CO17231</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>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071007309</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061101753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETAVASE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFLUDAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509029-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20070905119</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROPHTHALMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022040</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>37</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509031-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03540</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000460</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>X1;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20060703121</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071001660</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>21346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070806161</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AKATHISIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUANXOL DEPOT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100624</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>
      <patientweight>53.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METADATE CD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071006638</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TREATMENT NONCOMPLIANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100818</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019735</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2007BH008676</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007001786</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB(ERLOTINIB HCL) (TABLET) (ERLOTINIB HCL)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>800 MG,Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMOL(PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDINISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL(BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002006</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>159.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25MG-150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25MG-150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5MG-5MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5MG-5MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP01903</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>42.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDIOXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KN SUPPLEMENT 3B</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLACET-F</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02222</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPHARYNGEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOSERELIN</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>U2529</drugbatchnumb>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17712</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>10187</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSOR R</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007001758</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB(ERLOTINIB HCL) (TABLET) (ERLOTINIB HCL)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>450 MG,Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>50 MCG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30 MG PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>1 MG PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPPLEMENT NOS</medicinalproduct>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>900 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>90 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018851</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI000637</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAPUBIC CATHETER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019839</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOTROXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13946157</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE-780MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BAYER-200612022GDS</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>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DETACHMENT OF RETINAL PIGMENT EPITHELIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050906</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050906</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051022</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051022</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL ONCE DAILY</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANACOD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN COMP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008684</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11017</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008769</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706239</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200702480</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIDNEY MEDICATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706249</companynumb>
    <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>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-250681</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>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>400 MG/KG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>340 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT UNSPECIFIED DRUG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT UNSPECIFIED DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOPAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2006RR-04045</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 50MG</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250649</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509077-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008770</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250535</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509081-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007RR-11020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11042</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE816615OCT04</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509084-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-WYE-G00556107</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE559520JUN05</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050612</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00563107</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00554007</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>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-GENENTECH-250464</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>B2101, B2038</drugbatchnumb>
        <drugdosagetext>600 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250462</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>690 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>92 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE816915OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509093-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0417029-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</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>20060810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugauthorizationnumb>21324</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMONIA VACCINATION</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>10 MG AND 12.5 MG ALTERNATING DAYS</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO-BISMOL</medicinalproduct>
        <drugdosagetext>8 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008771</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008774</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAXTER-2007BH008773</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02215</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509105-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25327</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>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</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>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP06685</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509107-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>SEROQUEL 700MG/DAY SINCE 4/07</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugdosagetext>50MG IM Q2WKS X 2 YRS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-ELI_LILLY_AND_COMPANY-LB200710006803</companynumb>
    <primarysource>
      <reportercountry>LEBANON</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509113-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007034</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509114-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003618</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>500</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509116-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007498</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>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007081</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ELI_LILLY_AND_COMPANY-DK200706006204</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000077</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>LACUNAR INFARCTION</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>5509120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711000146</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>100 UG, 2/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>2 D/F, 4/D</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>100 UG, 4/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX200710007475</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007260</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200706005488</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>97.505</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugindication>ROSACEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000345</companynumb>
    <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200709003728</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007526</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006642</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.306</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, 3/D</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>16 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710004791</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006641</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVINOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509131-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ELI_LILLY_AND_COMPANY-TW200707004591</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>1.1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509132-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GBS050818233</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>560 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>30 D/F, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>7.5 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>16 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>280 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>120 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509133-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-05P-167-0304950-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0422800-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL XS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14224</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA_2007_0029868</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0420970-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </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>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0422667-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOSEDYL</medicinalproduct>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003408</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM LACTATE COMPOUND INJECTION</medicinalproduct>
        <drugdosagetext>80 ML/HR, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MATERNAL THERAPY TO ENHANCE FOETAL LUNG MATURITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI DEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-528789</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>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH AND FORMULATION TAKEN 10+20 MG CAPSULES.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE-35</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-527906</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED: INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-503939</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL VENOUS CATHETERISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATE-SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-486165</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021246</drugauthorizationnumb>
        <drugdosagetext>FORM: DRY SYRUP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHY-F</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESULAN</medicinalproduct>
        <drugdosagetext>FORM REPORTED AS FINE GRANULES.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-511044</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 1G BAG.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>FORM: EXTERNAL PREPARATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-524351</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>43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMPLANT SITE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>DRUG NAME: ALFASULY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugdosagetext>DRUG NAME: SOLDEM 3A (MAINTENANCE MEDIUM)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHR-FR-2007-040302</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040661</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>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>1062</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041288</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-041229</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033948</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>80.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040437</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>238</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUROTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENTTURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-032706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>.5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040408</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>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050321</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8744A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-032446</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-040656</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509179-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-040897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>31218A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-013469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHR-FR-2007-040299</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2007BH008715</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE512221JAN04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE539514AUG07</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>020377</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>020377</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-248816</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROXANE LABORATORIES, INC-2007-BP-23918BP</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018823</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509210-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200706003577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A276435</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1 G, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>2 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060824</drugenddate>
        <drugtreatmentduration>401</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.05 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509211-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOMYOLIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR OF THE STOMACH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugdosagetext>2 G, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.175 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL /USA/</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509212-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB TRAUMATIC AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</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>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509214-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006759</companynumb>
    <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>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A238707</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A223375</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006917</companynumb>
    <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>680</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50000 IU, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>10 U, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>70 U, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
        <drugdosagetext>50 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>110 UG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.354</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF SHUNT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</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>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugdosagetext>1500 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugdosagetext>1000 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006643</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A244255</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200710006453</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A383917</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD /POL/</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509219-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248651</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>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</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>PREDNISONE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23142BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509221-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23155BP</companynumb>
    <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>AGGRENOX</medicinalproduct>
        <drugbatchnumb>705726</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>705726</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509222-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23222BP</companynumb>
    <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 FLUCTUATION</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>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21969BP</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugbatchnumb>180</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZM-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06463GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>300 MG TENOFOVIR/200 MG EMTRICITABINE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509225-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-06401BP</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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED NON-BI STUDY DRUG</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-06331BP</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051122</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18385BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765022A,765038A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>19950101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509228-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23964BP</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20933</drugauthorizationnumb>
        <drugdosagetext>1.8ML ORAL ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugauthorizationnumb>020933</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509229-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2002-BP-03897BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509230-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22863NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>73.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20060414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060822</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID MIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBETOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509232-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23147BP</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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        <drugindication>NEPHROLITHIASIS</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5509233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdate>20071102</receiptdate>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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        <drugstartdate>20060203</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>5509234-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23520BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509235-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23009BP</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugdosagetext>80MG/12.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23518BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509237-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22915BP</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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509238-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22160BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugdosagetext>50/400</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22916BP</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22491BP</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23149BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509242-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23918BP</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018823</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZM-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06467GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugdosagetext>8 MG/KG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509244-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22869BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23041BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HTCZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23002BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509247-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23165BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704578B,7C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-06333BP</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-11924BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL TRANSFUSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509250-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20923BP</companynumb>
    <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765042A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509251-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21415BP</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070346W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070346W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugindication>OBSTRUCTIVE AIRWAYS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22982BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609894</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21838PF</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>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>7C2218</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>7C2218</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL FIBER LAXATIVE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERA-MILL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21107BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0613756</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23428BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>BLADDER NECK OBSTRUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22085PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23515BP</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0607509</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23765BP</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509259-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22621BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>077214</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21717BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <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>5509261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23576BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509262-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19738BP</companynumb>
    <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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDECRIN</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23156BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20830BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765047A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22784BP</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>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</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>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21964BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22124BP</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509268-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22097BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22325BP</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</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>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509271-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-09178BP</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL-MATERNAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248191</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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1230 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509276-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-GENENTECH-242603</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>AA5638</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIUM</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GENENTECH-248698</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ERYTHRODERMIC PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-230330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.888</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>7193</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-200716393GDS</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509281-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0712040US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KERATITIS HERPETIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>1 GTT, Q12H</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEARS</medicinalproduct>
        <drugdosagetext>UNK, Q2HR</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509282-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200510515BNE</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07100624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>063745</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>40 MG/M2, Q 28 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART (DUSTASTERIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE ER XL (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT (MECLOZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-LUPRON (LEUPRORELIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509284-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07080379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3377</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509285-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07080093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509286-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200716311GDS</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07040135</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URATE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL (FENTANYL) (POULTICE OR PATCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAUCOMA DROPS (ANTIGLAUCOMA PREPARATIONS AND MIOTICS) (DROPS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110092</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100191</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422695-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NODAL MARGINAL ZONE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAPROZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
        <drugdosagetext>10/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010116</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA EXERTIONAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509293-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07090213</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>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509294-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07090151</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X WEEKLY AFTER DIALYSIS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE037514OCT05</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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugbatchnumb>2004P1204; 2004P1021</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07081720</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>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL; 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL; 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-06070845</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</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>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101771</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-224729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN (DIETARY SUPPLEMENT)</medicinalproduct>
        <drugdosagetext>320 UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>400 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
        <drugindication>VAGINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5509303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421989-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5509305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
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    <receiptdate>20071030</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>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>X21 DAYS EVERY 28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071106</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0057C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 2 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101700</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
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        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07071010</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>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC LEUKAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIC LEUKAEMIA</drugindication>
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        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
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  <safetyreport>
    <safetyreportid>5509310-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0712185US</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19921</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07051645</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>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN  1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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  <safetyreport>
    <safetyreportid>5509312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07050163</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>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
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        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
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        <drugenddate>20070401</drugenddate>
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  <safetyreport>
    <safetyreportid>5509313-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <companynumb>DE-GENENTECH-250688</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
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        <drugindication>PSORIASIS</drugindication>
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        <drugstartdate>20061016</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509315-7</safetyreportid>
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    <receivedate>20071106</receivedate>
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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>53</patientonsetage>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5509316-9</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>
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        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD, ORAL</drugdosagetext>
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  <safetyreport>
    <safetyreportid>5509317-0</safetyreportid>
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    <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509319-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-247076</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DETACHMENT OF RETINAL PIGMENT EPITHELIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.05 MG, QD</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07090617</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG-20 MG, DAILY, ORAL; 10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG-20 MG, DAILY, ORAL; 10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509321-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101691</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101679</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07061135</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL, 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL, 5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101768</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101792</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL, 15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL, 15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL, 15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509327-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101787</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101741</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0360693-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0355427-00</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509333-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422878-00</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>088058</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>088058</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509334-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14100</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>20980</drugauthorizationnumb>
        <drugdosagetext>QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEA TREE OIL(MELALEUCA ALTERNIFOLIA OIL)</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509335-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007075396</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM FOR INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:25MG-FREQ:PRN</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMETHOLON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:125MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509336-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11354</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS MAX QDTABS ASST (NCH)(CALCIUM CARBONATE, SIMETH</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509337-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11293</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTIACID/ANTIGAS MAX STR MULTI SYMTOM (NCH)(MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugdosagetext>2 TSP, ONCE/SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURELL ORIGINAL (ETHYL ALCOHOL)</medicinalproduct>
        <drugdosagetext>UNSPECIFIED, OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE GLACIER MINT (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugdosagetext>3 TIMES A DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249302</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091434</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710USA06941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.9978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>4 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>75 MG/M[2]/DAILY PO; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>75 MG/M[2]/DAILY PO; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>1 DOSE/3XW/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509343-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-228225</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED.</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.727</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERY DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509345-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.09</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:5MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50MG-FREQ:ONCE AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugdosagetext>TEXT:1 DF-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091187</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509347-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007091169</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID TABLET</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENINGITIS TUBERCULOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509349-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021583</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugdosagetext>NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509350-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07-0086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>76899</drugauthorizationnumb>
        <drugdosagetext>1 TAB PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509351-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07080945</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0061C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALK_00428_2007</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVITROL</medicinalproduct>
        <drugauthorizationnumb>21897</drugauthorizationnumb>
        <drugdosagetext>(380 MG 1X/MONTH)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091150</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091127</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090964</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>011909</drugauthorizationnumb>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090931</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090968</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100371</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>428564</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100290</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509361-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05696-01</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>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>90 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>120 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05249-01</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>60 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509363-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>243</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER RELATED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090890</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>LUMBAR SPINAL STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090799</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509367-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007081279</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007086233</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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 SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABASERIL</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:8MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PK-MERZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOMORPHINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05692-01</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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509370-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007059684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007014006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTROCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.6MG-FREQ:DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (NEEDS NO REFRIGERATION)</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00402</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA01990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00792</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00013</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05666</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>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACOUSTIC NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL + D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00333</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
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  <safetyreport>
    <safetyreportid>5509379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <receiptdate>20071017</receiptdate>
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    <companynumb>JP-MERCK-0710USA02992</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>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00026</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0703USA04322</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZIMILIDE DIHYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0607USA02622</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>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0703USA03476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509384-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00914</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00025</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00551</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0710FRA00092</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06550</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509389-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00648</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</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>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509390-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0605USA02440</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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBUCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509391-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0608USA01320</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509392-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0704USA03307</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF PROSTATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006150111</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2006153700</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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>RENAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA00579</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0701GBR00201</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00031</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>
      <patientsex>1</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>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00137</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088015</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>020682</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>DAILY DOSE:24MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIKENTYUTO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091312</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>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509401-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>901880, 901981, 902578</drugbatchnumb>
        <drugdosagetext>15 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1250 MG/M2, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509402-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091451</companynumb>
    <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 USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0420640-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLADIO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0418483-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE</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>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050739</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079296</companynumb>
    <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES HARD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2007089329</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:2DROP</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMATE-P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD COAGULATION FACTORS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509407-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711906US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugbatchnumb>C1899</drugbatchnumb>
        <drugdosagetext>16 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-243728</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CYTOMEGALOVIRUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091028</companynumb>
    <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 STRESS TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509410-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007084861</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADECUT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-242345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2.7 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2006118394</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>022128</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCICORT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOFALK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509413-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05608-01</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>7.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006011735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULES</medicinalproduct>
        <drugauthorizationnumb>62644</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006108042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40000I.U.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40000I.U.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>TEXT:4 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:800MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>237392K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE (FLUOXETINE /00724401/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE (AMANTADINE /00055901/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235086K06USA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (COTYLENOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239206K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>237776K07USA</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239240K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238730K07USA</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007090972</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</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>TRIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091832</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007090989</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUARK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091868</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:4MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007057101</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM FOR INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HICALIQ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIDMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAJECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEYLON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239062K07USA</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>BENIGN LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG,3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>237102K07USA</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>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER STAGE IIIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG,3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE ER (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLIN (PENTOXIFYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX (MORNIFLUMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPO-N/APAP (PROPACET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (CENTRUM SILVER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA ALEXANDRINA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509430-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239207K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22  MCG,3 IN 1 WEEKS, SUBCUTANEOUS;  44 MCG,3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22  MCG,3 IN 1 WEEKS, SUBCUTANEOUS;  44 MCG,3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT (BLOPRESS PLUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238679K07USA</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>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG,3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239044K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>3 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METADATE CD</medicinalproduct>
        <drugauthorizationnumb>21259</drugauthorizationnumb>
        <drugdosagetext>10 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METADATE CD</medicinalproduct>
        <drugauthorizationnumb>21259</drugauthorizationnumb>
        <drugdosagetext>10 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003693</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>69.4003</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARASOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>2 MG;HS;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-SMOKING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007045070</companynumb>
    <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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>E344A</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007007489</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091074</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091031</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPEN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROZEPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDOL E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020181</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>81099</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFA()</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>019874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006143529</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007073700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugbatchnumb>07A716</drugbatchnumb>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007070956</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007068116</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ALLERGAN-200600613</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugbatchnumb>38815</drugbatchnumb>
        <drugdosagetext>1GTT, QID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CORNEAL GRAFT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051212</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
        <drugauthorizationnumb>017011</drugauthorizationnumb>
        <drugindication>CORNEAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020237</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>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>71773</drugauthorizationnumb>
        <drugdosagetext>APPROX. 50 G, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007067279</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMETAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711907US</companynumb>
    <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>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C1981</drugbatchnumb>
        <drugdosagetext>30 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007064656</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007067552</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007064658</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>71773</drugauthorizationnumb>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL(ACETAMINOPHEN) TABLET, 500MG</medicinalproduct>
        <drugdosagetext>250 G, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>96 MG; 1X; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163356USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACICLOVIR 200 MG CAPSULES (ACICLOVIR)</medicinalproduct>
        <drugauthorizationnumb>74578</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200700680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX, ANGIOMAX(BIVALIRUDIN) INJECTION</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509457-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007064628</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007065825</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509459-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091032</companynumb>
    <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014230</companynumb>
    <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>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509461-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007058395</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugauthorizationnumb>020379</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugauthorizationnumb>020379</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509462-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002368</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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A25864</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A25864</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A25864</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A25864</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A25864</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM (DIAZEPAM) HYDROCODONE + ACETAMINOPHEN (VICODIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE (DULOXETINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509463-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007075427</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugauthorizationnumb>050533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509464-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002239</companynumb>
    <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>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>(4.5 GM), ORAL; (6 GM), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>(4.5 GM), ORAL; (6 GM), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11861</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>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>3200 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007084203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14365</companynumb>
    <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>RENAL STONE REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007082254</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:37MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUSTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2007083270</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079228</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079408</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074472</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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISRADIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EDECRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509474-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007077727</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER HYPNOTICS AND SEDATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007078816</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOSARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509477-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007076316</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076820</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ABBOTT-07P-135-0371952-00</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>800/50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICYNE B</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOMAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KIDNEY INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007075698</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-PFIZER INC-2007088880</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCOAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>FREQ:0.5MG BID THEN 1MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002677</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>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>750 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM (TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2007087959</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>GENITAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLONEX DT</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509485-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007087403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYNOVIAL SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007086697</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE ^GLAXO WELLCOME^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007085892</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMILORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PHENOBARBITONE</medicinalproduct>
        <drugdosagetext>TEXT:EVERYDAY TDD:180MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PHENOBARBITONE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002295</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>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>125 MG, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5509490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007084941</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
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      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
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        <drugenddate>20071012</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090162</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>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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        <drugenddate>20060101</drugenddate>
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  <safetyreport>
    <safetyreportid>5509492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5509493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>FR-PFIZER INC-2007090259</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugauthorizationnumb>21928</drugauthorizationnumb>
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        <drugstartdate>20070404</drugstartdate>
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        <drugenddate>20070415</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIOLYTICS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5509494-1</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002673</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>EO60002</drugbatchnumb>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PI-02135</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAPREP ONE-STEP FREPP</medicinalproduct>
        <drugauthorizationnumb>20832</drugauthorizationnumb>
        <drugdosagetext>3-ML, ONCE, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL AND VERSAD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007090115</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXAPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007089811</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007089602</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.727</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04712</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugauthorizationnumb>22000</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>6N2902</drugbatchnumb>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>6N2902</drugbatchnumb>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>6N2902</drugbatchnumb>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>6N2902</drugbatchnumb>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugbatchnumb>6N2902</drugbatchnumb>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002661</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>BUCCAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>6 MG, UID/QD, ORAL ; 1.5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM (CITALOPRAM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETOPRIM + SULFAMETOXAZOL (TRIMETHOPRIM, SULFAMETHOXAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE# 07-019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75713</drugauthorizationnumb>
        <drugdosagetext>PLEASE SEE BLOCK 5.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091818</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>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091838</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091612</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>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>97O16</drugbatchnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509508-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091754</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugauthorizationnumb>018147</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091695</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugbatchnumb>NA0847</drugbatchnumb>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>FREQ:INJECTION</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONIN REUPTAKE INHIBITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.454</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0197</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091400</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091201</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007091386</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091210</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URIEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092450</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092554</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509524-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2006AU00474</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COITAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARMONY WOMENA??S PRE-MENSTRUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNER HEALTH PLUS DAIRY FREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092354</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugindication>IN VITRO FERTILISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092087</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007091881</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007091850</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091805</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>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007093072</companynumb>
    <primarysource>
      <qualification>1</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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092817</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>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>125607A</drugbatchnumb>
        <drugauthorizationnumb>019950</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:4.5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14407</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000475</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>21438</drugauthorizationnumb>
        <drugdosagetext>20 MG;Q6H;</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^ANTI-THYROID MEDICATION^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01773</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01772</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01748</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01771</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01745</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXTERNAL EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROQUINONE (UNSPECIFIED) (HYDROQUINONE) (HYDROQUINONE)</medicinalproduct>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01708</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>64108</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG,3 IN 1 DAYS)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFADROXIL</medicinalproduct>
        <drugdosagetext>1000 MG (500 MG,2 IN 1 DAYS)</drugdosagetext>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04243</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>61591</drugauthorizationnumb>
        <drugdosagetext>250MG, FOUR TIMES DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE-ALPHA (ALFACALCIDOL) (ALFACALCIDOL)</medicinalproduct>
        <drugdosagetext>1UG, THREE TIMES DAILY</drugdosagetext>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRATE (CALCIUM W/MAGNESIUM) (CALCIUM MAGNESIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>500MG  ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060619</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14412</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002351</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>D,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002333</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE (VALGANCICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL (COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004861</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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 LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004859</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002371</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP003988</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>44</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACACIL (BACAMPICILLIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP002081</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>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD; 1.5 MG, UID/QD; 2 MG, UID/QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD; 1.5 MG, UID/QD; 2 MG, UID/QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD; 1.5 MG, UID/QD; 2 MG, UID/QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL(BUCILLAMINE) FORMULATION UNKNOWN</medicinalproduct>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPEN (MINOCYCLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007090024</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugauthorizationnumb>20114</drugauthorizationnumb>
        <drugdosagetext>1096 MCG (548 MCG,2 IN 1 D), IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugauthorizationnumb>20114</drugauthorizationnumb>
        <drugdosagetext>1096 MCG (548 MCG,2 IN 1 D), IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>VASOMOTOR RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002242</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD 30 (INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP14106</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4/CD8 RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD8 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>75 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/D, ORAL; 22.5 MG/D, ORAL; 25 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/D, ORAL; 22.5 MG/D, ORAL; 25 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENOSINE (GANCICLOVIR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09189</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOHEXAL (NGX)(METOPROLOL) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>73288</drugauthorizationnumb>
        <drugdosagetext>69.6 MG EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>69.6 MG EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1044, EVERY 21 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NANDRAN()</medicinalproduct>
        <drugdosagetext>5 MG, EVERY 21 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXANE(UROMITEXANE)</medicinalproduct>
        <drugdosagetext>2X200 MG, EVERY 21 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000476</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROTOXIC CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>21438</drugauthorizationnumb>
        <drugdosagetext>40 MG; BID;</drugdosagetext>
        <drugindication>PALPITATIONS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004585</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>77345</drugauthorizationnumb>
        <drugdosagetext>100 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002044</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>/D</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002370</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>/D</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU002369</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>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>/D</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14396</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-LLY01-GB200707003941</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KIDNEY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-008481-07</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-008476-07</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03536</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>1/2 TAB OCCASIONAL</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.4619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100 MG 1 QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MGM P.O. QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.1521</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>PP2356</drugbatchnumb>
        <drugdosagetext>90MCG PRN INHAL</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM COLD REMEDY NASAL GEL</medicinalproduct>
        <drugbatchnumb>27151V</drugbatchnumb>
        <drugdosagetext>1 PUMP IN EACH NOSTRIL EVERY 4 HOURS ENDOSINUSIAL</drugdosagetext>
        <drugadministrationroute>006</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>I TABLET TWICE DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHEDENT DENTAL CREAM 1.1% SODIUM FLUORIDE (ETHEX)</medicinalproduct>
        <drugbatchnumb>70130</drugbatchnumb>
        <drugdosagetext>ONE ORAL BRUSHING DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 7/7/7(NORETHINDRONE/ETHINYL ESTRADIOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENGRAF</medicinalproduct>
        <drugbatchnumb>49647AF23</drugbatchnumb>
        <drugdosagetext>75 MG TWICE DAILY PO MANY YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugbatchnumb>BE8131625 LI 0232</drugbatchnumb>
        <drugdosagetext>200MG 2X</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
        <drugdosagetext>10 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGLECT OF PERSONAL APPEARANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG DAY 1-3  1 TAB  4-7 0.5 2X DAY   7TH DAY 1MG 2 X DAY</drugdosagetext>
        <drugindication>CONDITION AGGRAVATED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG DAY 1-3  1 TAB  4-7 0.5 2X DAY   7TH DAY 1MG 2 X DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALL'S MENTHO-LYPTUS</medicinalproduct>
        <drugdosagetext>1 LOZENGE</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG Q 12 HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG Q 12 HRS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>3 MG Q 3 MOS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREFOLIN NAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA + D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG Q WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP14631</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14322</companynumb>
    <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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>^180MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>360 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US15285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1.44 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>275 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, Q12H</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT16626</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
        <drugdosagetext>20 MG/DIE, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>915</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE17547</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>2880 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14463</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</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>19758</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03650</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14234</companynumb>
    <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18299</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18300</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NL18170</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03240</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18307</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17338</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG 1 PO QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>53.0709</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.2 1 PATCH QD PATCH</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18196</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMOLINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14358</companynumb>
    <primarysource>
      <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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.852</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugauthorizationnumb>020363</drugauthorizationnumb>
        <drugdosagetext>500MG Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02893</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18041</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIBOLONE</medicinalproduct>
        <drugdosagetext>2.5MG, QD</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILACORON</medicinalproduct>
        <drugdosagetext>120MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR16336</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARFORM</medicinalproduct>
        <drugauthorizationnumb>21204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALVUS</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850 MG, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14134</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR18213</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPORTS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN TRIPLE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007GB17018</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>66.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>813</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP12909</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO DOPASTON</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugdosagetext>0.75 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE13612</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>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEB071 VS MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>50791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US05967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.517</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR10189</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXACILLIN</medicinalproduct>
        <drugdosagetext>2G Q4? IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXACILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20MG 1QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPRION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18305</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02206</companynumb>
    <primarysource>
      <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>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18254</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTANOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <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>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18115</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>12 / 400 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005US10718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADRENAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>DOUBLE-BLIND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>017851</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17943</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLASHBACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN18199</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIKELAN (NVO)</medicinalproduct>
        <drugauthorizationnumb>19972</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02406</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>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MERCAZOLE TAB</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>SINUS TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, QD</drugdosagetext>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMAXOL</medicinalproduct>
        <drugdosagetext>10 DROPS/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MG/M2 IV Q4WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250MG/M2 IV QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>750 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>7MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientweight>60.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>10MG X 1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25/20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.3MG QWEEK TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.3MG QWEEK TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>2MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugdosagetext>40MG OTHER SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10MG QWEEK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNITS BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.2MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.9978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN 25MG CAP</medicinalproduct>
        <drugdosagetext>50MG TID PRN PAIN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN 25MG CAP</medicinalproduct>
        <drugdosagetext>50MG TID PRN PAIN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (B/C CONTAINS APAP)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>NOT AVAILABLE NOT AVAILABLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugdosagetext>150MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY EVENING PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY EVENING PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM ORAL POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 500 MG/VITAMIN D 200 UNITS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>130.6359</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>25 MG PER WEEK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL MDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINOLONE OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN AC SYRUP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN SA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1.5 TABS (11.25MG) S,S,M,T,R,F PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 TABS (15MG) W PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPROMIDE (300 MILLIGRAMS IODINE/MILLILITER)</medicinalproduct>
        <drugdosagetext>200 ML ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBOPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugdosagetext>200 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugdosagetext>200 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5ML PRN IV FLUSH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRAVENOUS CATHETER MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>300 MG BID PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS, CONJUGATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>0955284-02703</drugbatchnumb>
        <drugdosagetext>1 PILL3TIMES DAILY(EVERYDAY)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugbatchnumb>1084099-02703</drugbatchnumb>
        <drugdosagetext>1PILL AT NIGHT EVERYNIGHT</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>90 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>90 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250 MG.PER METER SQUARED WEEEKLY IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>50 MG PER METER SQUARED TWICE A WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>1 TAB DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>1 TAB DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELADIL CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>553852E80</drugbatchnumb>
        <drugdosagetext>2OOMG 2 TIMES DAY EVERY DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>567812E21</drugbatchnumb>
        <drugdosagetext>200MG 2 TIMES DAY EVERY DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>2 PUFFS AM AND 1 PUFF PM QD-BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 80MG TABLETS TEVA</medicinalproduct>
        <drugbatchnumb>04S085</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100421</companynumb>
    <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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUSTATIN</medicinalproduct>
        <drugauthorizationnumb>020229</drugauthorizationnumb>
        <drugdosagetext>SINGLE COURSE OF 7 DAY IV INFUSION, DOSE APPROX. 60-62MG</drugdosagetext>
        <drugindication>LANGERHANS' CELL GRANULOMATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (NEEDS NO REFRIGERATION)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES INSIPIDUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007424</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101840</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100089</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0707796</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0702241;0701671</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>100UG/HR + 25UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20060102132</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100680</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>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORETHINDRONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>016954</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVYSMEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPEMAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070403352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070107733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATED MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100327</companynumb>
    <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 FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LV-AVENTIS-200720086GDDC</companynumb>
    <primarysource>
      <reportercountry>LATVIA</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugbatchnumb>F019V05</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE QUANTITY: 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 200</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>ADQ81B</drugbatchnumb>
        <drugdosagetext>4-6 PUFFS 10 + TIMES A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200709001750</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710004703</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, IRREGULAR INTAKE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>111.1313</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugbatchnumb>BOX AT HOME</drugbatchnumb>
        <drugdosagetext>24 HRS CUTANEOUS</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ELI_LILLY_AND_COMPANY-SE200710007597</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711000386</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID FUNCTION TEST ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200704005210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.608</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, EACH EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060527</drugenddate>
        <drugtreatmentduration>2979</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>25 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, EACH MORNING</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010802</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710005518</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710003638</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.816</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>AGITATED DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG, 4/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>350 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR200711001125</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000348</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>021520</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>021520</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG, 3/D</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200709001756</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION STAPHYLOCOCCAL</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>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </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>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL /SCH/</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugdosagetext>1 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000936</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 10 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 10 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 3MG X 1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 8 MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 7.5MGX1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPODUR</medicinalproduct>
        <drugdosagetext>DEPODUR 10MG X1 EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>01/07/06 100MG ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>01/07/06 100MG ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RED BLOOD CELL COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>01/07/06 100MG ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>01/07/06 100MG ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RED BLOOD CELL COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>P060097</drugbatchnumb>
        <drugdosagetext>100MG. Q.D./S.C.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>P060097</drugbatchnumb>
        <drugdosagetext>100MG. Q.D./S.C.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLOBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB, 250MG/M2</medicinalproduct>
        <drugdosagetext>250 MG/M2 WEEKLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC=2 WEEKLY X 3 + 1 WK OFF IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00562907</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>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04241</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN (ERYTHROMYCIN) (ERYTHROMYCIN)</medicinalproduct>
        <drugauthorizationnumb>61591</drugauthorizationnumb>
        <drugdosagetext>250 MG FOUR TIMES A DAY; 500 MG (2 DOSES GIVEN 6 HOURS APART)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS URINARY TRACT INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
        <drugbatchnumb>A0600827</drugbatchnumb>
        <drugdosagetext>ONE PILL ONCE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>300 300 400 2000MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-166574-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>20214</drugauthorizationnumb>
        <drugdosagetext>0.9 MG/KG ONCE/10 MG ONCE; {1 MONTH; INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>20214</drugauthorizationnumb>
        <drugdosagetext>0.9 MG/KG ONCE/10 MG ONCE; {1 MONTH; INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>20214</drugauthorizationnumb>
        <drugdosagetext>0.9 MG/KG ONCE/10 MG ONCE; {1 MONTH; INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>INJECT 25MG ONCE WEEKLY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>162994ISR</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>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74656</drugauthorizationnumb>
        <drugdosagetext>(50 MG/M2, OVER 4H DAYS 3 AND 4)</drugdosagetext>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>(90 MG/M2, DAYS 1-4 OVER 2 H)</drugdosagetext>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugdosagetext>(1 MG/M2)</drugdosagetext>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1MG 2X DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>161686ISR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D); 20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D); 20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND: 250 OR 500 MICROGRAM</drugdosagetext>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>1 GRAM (1 GRAM, 1 IN 1 D); 300 MG (300 MG, 1 IN 1 D) INTRAVENOUS (NOT OTHERWISE SPECIFIED); ORAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>1 GRAM (1 GRAM, 1 IN 1 D); 300 MG (300 MG, 1 IN 1 D) INTRAVENOUS (NOT OTHERWISE SPECIFIED); ORAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>1 GRAM (1 GRAM, 1 IN 1 D); 300 MG (300 MG, 1 IN 1 D) INTRAVENOUS (NOT OTHERWISE SPECIFIED); ORAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050902</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>50 MG (50 MG,1 IN 1 D) INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>800 MG (400 MG,2 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051017</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELACODID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugdosagetext>25MG DAILY 21D/28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>INJECT 480MCG DAILYFOR4DAYSQ2WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>INJECT 480MCG DAILYFOR4DAYSQ2WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>INJECT 480MCG DAILYFOR4DAYSQ2WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TRACHEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN 150 MG PE/2ML- 100 MG</medicinalproduct>
        <drugdosagetext>544 MG PE ONCE IV BOLUS 136,108.8, 81.6, 68 MG PE ONCE IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOSPITALISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPLENIC RUPTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>97.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1.3MG/M2 ON DAYS 1 + 4</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375MG/M2 ON DAY 1</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN (AMOXICILLIN/CLAV.ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL #3 (ACETAMINOPHEN W/CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN (CHEMO N/V) (ONDANSETRON HCL (CHEMO N/V))</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163149ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</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>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75972</drugauthorizationnumb>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOACETYLSALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10MG/KG I.V. Q 2WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10MG/KG I.V. Q 2WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10MG/KG I.V. Q 2WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10MG/KG I.V. Q 2WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100MG P.O. QD 21DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100MG P.O. QD 21DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100MG P.O. QD 21DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100MG P.O. QD 21DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-1163355</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugauthorizationnumb>20816</drugauthorizationnumb>
        <drugdosagetext>1 GTT BID</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRONAJOD (JODTHYROX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-FLUORETTEN (D-FLUORETTEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AARANE                   (ALLERGOSPASMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS               (DESLORATADINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1190 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>0 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugdosagetext>0 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>175 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001049</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>77882</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>24000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>47 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>465 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001218</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>78199</drugauthorizationnumb>
        <drugdosagetext>250 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPACRINE               (MEPACRINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>6PHT4</drugbatchnumb>
        <drugdosagetext>1450 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>5JFL14</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>88 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>79 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF (FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>282 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>715 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>343 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY OTC NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001213</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>40774</drugauthorizationnumb>
        <drugdosagetext>25 MG;TAB;PO;QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>40774</drugauthorizationnumb>
        <drugdosagetext>25 MG;TAB;PO;QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>40774</drugauthorizationnumb>
        <drugdosagetext>25 MG;TAB;PO;QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>2MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711198BVD</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>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIOVAN 160/12.5</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BAYER-200611784GDS</companynumb>
    <primarysource>
      <reportercountry>EL SALVADOR</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712107BWH</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 1000 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200711384BWH</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>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3-6-9</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GREEN TEA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200711686BWH</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>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugdosagetext>AS USED: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200510548BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN IV</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHOLANGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN IV</medicinalproduct>
        <drugauthorizationnumb>019847</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>AS USED: 5 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 50 MG  UNIT DOSE: 50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 2 G  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 200 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 300</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 140 ML  UNIT DOSE: 300 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>80MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>330MG OTHER IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>510MG OTHER IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>2MG OTHER SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR200711000085</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-WYE-H01096807</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>5.75 MG (CUMULATIVE DOSE 7.25 MG) FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugdosagetext>DOSE AND FREQUENCY  NOT SPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>300MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE</medicinalproduct>
        <drugdosagetext>38MG OTHER IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugdosagetext>2MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOCUMENTED HYPERSENSITIVITY TO ADMINISTERED DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>?MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18391</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>200 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>50 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>2 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18203</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBAREN T30087+FCTAB</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>50 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>300MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>5MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>1MG PRN SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>40MBQ EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>40MBQ EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>55UNITS BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5000UNITS BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20MEQ EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20MEQ EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20MEQ EVERY DAY PO -} DECREASED 16 MEQ ON 7/20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40MG EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE187013JUL05</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>TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugauthorizationnumb>50621</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050505</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050502</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050505</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007682</companynumb>
    <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 VALVE VEGETATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>SWEAT GLAND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20071007989</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071001769</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>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <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>THYRADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</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>2</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200603005450</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-267881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>TP50596</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>TP50414</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268446</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-266271</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugbatchnumb>SH70989</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXAGON                             /01479301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>538</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>140.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02037</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>523</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>103.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REMOVAL OF FOREIGN BODY FROM GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>485</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA/SYMBYAX (OLANZAPINE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>514</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>127.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-200 MG ON 10-SEP-2002-AUG-2004, 200-300MG ON SEP-2004 TO PRESENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-200 MG ON 10-SEP-2002-AUG-2004, 200-300MG ON SEP-2004 TO PRESENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16901</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>62.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010226</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031116</drugenddate>
        <drugtreatmentduration>993</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-268979</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>22 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPRIL                            /00574901/</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>5000 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE305525SEP07</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>23624</drugbatchnumb>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00538907</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-WYE-G00538807</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO HALF</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710962BNE</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714276BWH</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716568GDS</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>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>20</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>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713608BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>AS USED: 400/200 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00567207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H00667407</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CHLAMYDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060903</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED GEL DOSAGE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELTOUCH</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugauthorizationnumb>018922</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060921</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H00974407</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANADIN IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>8 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>8200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-07P-151-0422939-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL EPIGLOTTAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HEARING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW SET EARS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</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>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF(FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>288 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>950 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>95 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1190 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>77 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>69 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF(FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>245 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>G-CSF(FILGRASTIM, AMGEN)</medicinalproduct>
        <drugdosagetext>150 MCG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8000 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB(MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007FR03298</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>77656</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugdosagetext>2 MG, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOPASS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007BR02907</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALSAN (NCH)(CALCIUM CARBONATE) TABLET</medicinalproduct>
        <drugbatchnumb>Z0023</drugbatchnumb>
        <drugdosagetext>5 0% OF THE TAB, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>146.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>846 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>350 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007BR02908</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>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALSAN  (CALCIUM CARBONATE)</medicinalproduct>
        <drugbatchnumb>Z0023</drugbatchnumb>
        <drugdosagetext>5% OF THE TAB, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>76.6579</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334232</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE EYE DROPS</medicinalproduct>
        <drugdosagetext>15 ML ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17821</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugdosagetext>12 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050628</drugenddate>
        <drugtreatmentduration>1786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGHT TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUTROGENA DEEP CLEAN FACIAL CLE NEUTROGENA CORPORATION</medicinalproduct>
        <drugdosagetext>TWICE DAILY TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OILY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509886-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AVENTIS-200719865GDDC</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>OSTEOMYELITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>WOUND INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-AVENTIS-200715059GDDC</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 12 MG</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1 G/M2 SYTEMICALLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>080472</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 6 G/M2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: INTRATHECAL AND SYSTEMIC</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: INTRATHECAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 4000CGY (PERFORMED IN 20 FRACTIONS)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713470FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLASTOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-AVENTIS-200715053GDDC</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 12 MG</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>080472</drugauthorizationnumb>
        <drugdosagetext>DOSE: 24 MG</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 30 MG</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 3000CGY IN 20 FRACTIONS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712960JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712968JP</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>53.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL                             /01178101/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN                            /00890701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPEC                              /00014302/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEW LECICARBON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0701USA03045</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO (UNSPECIFIED) UNK</medicinalproduct>
        <drugdosagetext>PO ; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712970JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE: 65 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL                             /01178101/</medicinalproduct>
        <drugdosagetext>DOSE: 3 MG</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>DOSE: 75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN                            /00890701/</medicinalproduct>
        <drugdosagetext>DOSE: 60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSE: 20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056C-B</drugbatchnumb>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0154B-B</drugbatchnumb>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AVENTIS-200720178GDDC</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>20496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENITEN                            /00574902/</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOREM                              /01036501/</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL                           /01263202/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0705USA01911</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO (UNSPECIFIED) UNK</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO (UNSPECIFIED) UNK</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL ARGININE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710AUS00204</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugauthorizationnumb>22145</drugauthorizationnumb>
        <drugdosagetext>400 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugdosagetext>200 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE 1.5MG TAB</medicinalproduct>
        <drugdosagetext>2 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CASTLEMAN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32.2054</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0705USA01911</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>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (UNSPECIFIED) UNK</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (UNSPECIFIED) UNK</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL ARGNINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200720050GDDC</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugbatchnumb>D238</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: ACCORDING TO GLYCEMIA</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIFAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-WYE-H01036407</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2007BH003225</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>06H29G43</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>06I12G41</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>06J19G42</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRINEAL NOS WITH AMINO ACIDS</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESENIUS ISO-OSMOLAR SOLUTION</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL /FRA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25096</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25307</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509909-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugdosagetext>0.5MG/2ML</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugdosagetext>0.5MG/2ML</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>REDUCED DOSE TO .63 MG IN 2007</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>REDUCED DOSE TO .63 MG IN 2007</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW26964</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>1827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>1827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugbatchnumb>?036145361</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>1827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugbatchnumb>?036145361</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>1827</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004889</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 DF, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>2.7216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPITUITARISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>1X DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100MG 2 TIMES PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.5453</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>3 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0204</drugbatchnumb>
        <drugdosagetext>1 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004876</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCILLAMINE (BUCILLAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT (ETANERCEPT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25393</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>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUCLEO CMP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW13787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003406</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>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugauthorizationnumb>088584</drugauthorizationnumb>
        <drugdosagetext>4 TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC INTERVENTION SUPPORTIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003407</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugauthorizationnumb>088584</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>27.8509</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1.6 MG/M2 DAYS 1+8 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>15 MG/KG DAY 1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>69.09</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>1 G Q24H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU001450</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</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>CHOLANGITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL AND PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS)</medicinalproduct>
        <drugdosagetext>1 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL AND PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL AND PANCREAS TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000MG/M2 EVERY OTHER WEEK INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB GENENTECH</medicinalproduct>
        <drugdosagetext>10MG/KG EVERY OTHER WEEK INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004837</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0030017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509928-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0703776;0702238</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900478</companynumb>
    <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>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040501450</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>10 MG, UP TO SIX PER DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101517</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>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101551</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>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20070903165</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>5509935-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007774</companynumb>
    <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25 MG IN AM; 25 MG IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFANTS MYLICON NON-STAINING FORMULA</medicinalproduct>
        <drugbatchnumb>MLF043</drugbatchnumb>
        <drugdosagetext>^LESS THEN 0.3 ML (20 MG)^ TWICE, TOTAL</drugdosagetext>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101549</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>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-AVENTIS-200715162EU</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016363</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>28000423</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200715081EU</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugauthorizationnumb>018538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETEN                            /01347301/</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200715127EU</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugauthorizationnumb>018538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                           /00002703/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-AVENTIS-200720198GDDC</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</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>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200715161EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIQUIN                            /01068203/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARTAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200711759DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BIOPSY CHORIONIC VILLOUS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AVENTIS-200715150EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL CORD HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLEXANE                            /01708202/</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2000AU04068</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>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UP TO 750 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000605</drugenddate>
        <drugtreatmentduration>1955</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>750MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250250</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>114</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IDIOPATHIC PNEUMONIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSCARNET SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-US250310</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL248356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070225</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004835</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2007BH008675</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECITABINE 50 MG UNKNOWN</medicinalproduct>
        <drugdosagetext>10 MG 1 HOUR X 5 DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>.7ML BASED UPON WT. WEEKLY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004828</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT 7.5 MG KIT</medicinalproduct>
        <drugdosagetext>INJECT 7.5MG MONTHLY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>102.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAZACLO AZUR PHARMA</medicinalproduct>
        <drugdosagetext>200MG EVERY MORNING PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAZACLO AZUR PHARMA</medicinalproduct>
        <drugdosagetext>100MG EVERY EVENING PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004619</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EVANS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>ORAL; 0.1 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIROVEC (ACICLOVIR) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE (PREDNISOLONE) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADSORBIN (ALUMINIUM SILICATE) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANNALBIN (ALBUMIN TANNATE) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON (LANSOPRAZOLE) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN (STREPTOCOCCUS FAECALIS, LACTOBACILLUS ACIDOPHILUS, BACILLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE (SODIUM POLYSTYRENE SULFONATE) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBALL GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN (VITAMINS NOS) GRANULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE (CALCIUM LACTATE) GRANULE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP003883</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>46.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, /DAY,  ORAL; 5 MG, UID/QD,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, /DAY,  ORAL; 5 MG, UID/QD,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, IUD/QD,  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART (AZOSEMIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC) POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENOPAMINE (DENOPAMINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN (BROTIZOLAM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINZAIN (TRIAZOLAM) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>107.9561</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELOCOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICAZONE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL -ACETAMINOPHEN- ARTHRITIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN SL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE 20MG LILLY</medicinalproduct>
        <drugdosagetext>10-60MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE 20MG LILLY</medicinalproduct>
        <drugdosagetext>10-60MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029967</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>60 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>INJECT 300MG-2DIFFERENT EVERY 4 WEEKS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5349</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>0.5 MG ONE TAB A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-UKI-05684-01</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLOPPY IRIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG DAILY P.O.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05678-01</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>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM ORAL SOLUTION (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21046</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>10MG LEVITRA APPROX ONCE A MONTH ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>50MG VIAGRA APPROX ONCE A MONTH ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NLD-05777-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugbatchnumb>C1832 C2</drugbatchnumb>
        <drugdosagetext>150 UNITS, ONCE, IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugbatchnumb>C1832 C2</drugbatchnumb>
        <drugdosagetext>150 UNITS, ONCE, IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PERONEAL NERVE PALSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509971-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.5453</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>3 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509972-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0355779-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A232255</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A232255</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0349874-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0354767-00</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0350866-00</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0351156-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509977-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0356468-00</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0356203-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugdosagetext>2 TABS QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-UKI-05776-01</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOREOATHETOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0349216-00</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>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0357127-00</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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0350299-00</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>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-02P-163-0192448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509984-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0354245-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN 60 MG/10ML AMPULES</medicinalproduct>
        <drugdosagetext>.08 MG/KG -56.5 MG- Q 8 H FPR 16 DOSES IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE 20 ML VIAL GENZYME</medicinalproduct>
        <drugbatchnumb>89781052</drugbatchnumb>
        <drugdosagetext>30 MG/M2 -54 MG- DAILY IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-IRL-05775-01</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR INVASION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000MG/M2 EVERY OTHER WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB GENENTECH</medicinalproduct>
        <drugdosagetext>10MG/KG EVERY OTHER WEEK IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0056C-B</drugbatchnumb>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250105</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1200 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>89 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>161 MG, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509993-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0154B-B</drugbatchnumb>
        <drugdosagetext>5MG EVERY OTHER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509995-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1MG 2 TIMES A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>1 MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>130 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugdosagetext>60 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>180 TIMES ONE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5509999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247316</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>94.331</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>6 UNIT, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>24 UNIT, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>50 A?G, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>INJECTION SITE PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245800</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>25 MG/ML, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NOR-05759-01</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT OROS (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-GER-05779-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0357675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0357439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0371675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>CHLAMYDIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0370066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365221-00</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0368626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070520</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0369842-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0368931-00</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0372497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>1 PUFF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMACORT</medicinalproduct>
        <drugdosagetext>1 PUFF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
        <drugdosagetext>1 BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>2.0 MG FOR 5 DAYS, 1 MG 2 DAYS A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0371702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0366313-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0422684-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510017-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0375444-00</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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510018-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422217-00</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>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILM TABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19650101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418900-00</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOT REPORTED MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510020-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0275015-00</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH-DOSE DIURETICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0350388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>06TK441018</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0352568-00</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0370548-00</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL/VERAPAMIL</medicinalproduct>
        <drugbatchnumb>411938D</drugbatchnumb>
        <drugauthorizationnumb>20591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365716-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugdosagetext>TAKEN FOR 2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0357563-00</companynumb>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0363190-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0376729-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05778-01</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0358545-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0353347-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0354311-00</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0361824-00</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0370344-00</companynumb>
    <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>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0367402-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0364359-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0367070-00</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0372038-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0366589-00</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILM TABS</medicinalproduct>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0375602-00</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILMTABS</medicinalproduct>
        <drugbatchnumb>460022Z</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>460022Z</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>460022Z</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0376091-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0375881-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0374550-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENPROPERINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0416480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422188-00</companynumb>
    <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>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0349702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417103-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0366179-00</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0371189-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>411938D</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0361763-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0374792-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugdosagetext>4/240MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAVERINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0376780-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEGY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378126-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0701USA03045</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510061-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>144-C5013-07070493</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>
      <patientweight>85.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, EVERY DAY, DURING 21 DAYS</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0354335-00</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>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0358788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.952</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>COLECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>COLECTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>104-C5013-07060212</companynumb>
    <primarysource>
      <reportercountry>MARTINIQUE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013         (LENALIDOMIDE)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0369935-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM CHELONEI INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0358957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365900-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.934</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510070-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILMTABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415519-00</companynumb>
    <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>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0375719-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILMTABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILMTABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>THROAT IRRITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418770-00</companynumb>
    <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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOSALBUTAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418061-00</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421294-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN FILMTABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421595-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0350815-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-05P-163-0311696-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20591</drugauthorizationnumb>
        <drugdosagetext>2 MG/240MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugbatchnumb>114558</drugbatchnumb>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEN-NITRO</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0365373-00</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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0352607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0354460-00</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINE ABNORMALITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTNASAL DRIP</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0359814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0361770-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0358880-00</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA 2 MG/180 MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20591</drugauthorizationnumb>
        <drugdosagetext>2/180 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0362934-00</companynumb>
    <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>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0416870-00</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0371672-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377080-00</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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377100-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07070156</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAY 1-21, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, DAY 1-4, 9-12, 17-20</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-21880-07101590</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NLD-05637-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCAL                   (CARBASALATE CALCIUM)</medicinalproduct>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR                (ULTRACET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378054-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERIAD</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0342484-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021251</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421713-00</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.317</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT TISSUE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417028-00</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>BLOOD TRIGLYCERIDES INCREASED</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>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415240-00</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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007960</companynumb>
    <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 TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugdosagetext>1X 100UG/HR PLUS 1X 50UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>2X 100UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061204680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101453</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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugdosagetext>INGESTED ONE TABLET ONLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20070901814</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGASM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071101019</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070421</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071100177</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-NLD-05637-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCAL (CARBASALATE CALCIUM)</medicinalproduct>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON (PREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR (ULTRACET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01490</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-BLOCKING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEVER'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020441</drugauthorizationnumb>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</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>PULMICORT RESPULES</medicinalproduct>
        <drugdosagetext>0.5 MG/2ML BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2005UW03681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-150 MG PO HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25402</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEDILANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06265</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28314</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROPENT</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01542</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18803</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW23544</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>86.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugbatchnumb>6317145341</drugbatchnumb>
        <drugauthorizationnumb>021229</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510118-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP03302</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2005CG01697</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25651</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</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>20050817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINIPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250296</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P099846</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-US251214</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ENBREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-US240205</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510123-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-US246484</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US245155</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510125-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KADN20070102</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPERISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510126-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11953</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>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00831</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACANTHAMOEBA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.49 MG, INTRAVENOUS; 1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.49 MG, INTRAVENOUS; 1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACIN              (ISEPAMICIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID                 (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE                    (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX002606</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>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>; PO, 1500 UG; QD; PO, 1250 UG; QD; PO, 1000 UG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>; PO, 1500 UG; QD; PO, 1250 UG; QD; PO, 1000 UG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>; PO, 1500 UG; QD; PO, 1250 UG; QD; PO, 1000 UG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>; PO, 1500 UG; QD; PO, 1250 UG; QD; PO, 1000 UG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA                       BENSERAZIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510129-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001814</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINUM NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>140 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>480 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR                      (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASTET                      (ETOPOSIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN       (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002622</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 3A (SODIUM LACTATE, POTASSIUM CHLORIDE, CARBOHYDRATES NOS, SODI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO HEPARIN                             (HEPARIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGACIN                  (BIAPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS           /CARBOHYDRATES/MINERALS/VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL-MELCORT              (METHYLPREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071000327</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510132-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002488</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON           (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE HYDROGEN SUCCINATE    (HYDROCORTISONE HYDROGEN SUCCINAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008447-07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSE WAS TITRATED DOWN FROM 48MG TO 16MG PER DAY OVER TIME.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>4 TABLETS A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510136-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-008363-07</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RB-008272-07</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510138-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-008422-07</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008406-07</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHARCOAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN AMOUNT GIVEN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JIMSON SEEDS</medicinalproduct>
        <drugdosagetext>PATIENT STATED HE ATE A POT FULL OF JIMSON SEEDS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSOSTIGMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510140-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008152-07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008470-07</companynumb>
    <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510142-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008478-07</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510143-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245807</companynumb>
    <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 OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>2.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOTHALAMO-PITUITARY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20071004579</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>IRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20071004579</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>IRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510146-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13664537</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugauthorizationnumb>021064</drugauthorizationnumb>
        <drugdosagetext>DILUTED VIAL IN 8CC NS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ECHOCARDIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13939210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510148-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13964416</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugdosagetext>INITIAL DOSE FROM 12-DEC-2006 TO 03-OCT-2007 AND RESTARTED ON 23-OCT-2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13969738</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>TRIAMCINOLONE</medicinalproduct>
        <drugauthorizationnumb>011283</drugauthorizationnumb>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugauthorizationnumb>011283</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugauthorizationnumb>011283</drugauthorizationnumb>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510150-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971080</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>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANDROGEN DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510151-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13971510</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILE DUCT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugauthorizationnumb>62336</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13969795</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13908413</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>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>THERAPY DATE: 29-MAY-07 TO 29-MAY-07; 03-JUL-07 TO 30-JUL-07</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>THERAPY DATE: 29-MAY-07 TO 29-MAY-07; 03-JUL-07 TO 30-JUL-07</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>THERAPY DATE: 29-MAY-07 TO 29-MAY-07; 03-JUL-07 TO 30-JUL-07</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOPROPIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANNALBIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510154-1</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071031</receiptdate>
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    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13913165</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>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM = 24 G/M**2.</drugdosagetext>
        <drugindication>NEUROECTODERMAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugindication>NEUROECTODERMAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>NEUROECTODERMAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>070867</drugauthorizationnumb>
        <drugindication>NEUROECTODERMAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
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    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13969779</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>FIRST 4 DOSES FROM SEP-2004 - DOSE NOT STATED. NEXT 2 DOSES FROM DEC-2004 - 60 MG/M2 ON DAY.</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugdosagetext>FIRST 4 DOSES FROM SEP 2004 - DOSE NOT STATED. NEXT 2 DOSES FROM DEC 2004 - 120 MG/M2 ON DAYS 1-3</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13970843</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>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICNU PWDR FOR INJ</medicinalproduct>
        <drugauthorizationnumb>17422</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE-TEVA</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE TEVA</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELVORINE</medicinalproduct>
        <drugdosagetext>ELVORINE IV 175MG/17.5ML.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13862206</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugauthorizationnumb>19856</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM = 25/100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERFALGAN IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL FRESENIUS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXACILLIN SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13972245</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>PANCREATITIS ACUTE</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>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>1 DOSAGEFORM = 10 UNSPECIFIED UNIT.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13968300</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>CHOLECYSTECTOMY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>4 DOSES OF ORENCIA IS GIVEN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510160-7</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071105</receiptdate>
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    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13969852</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
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      <drug>
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      <drug>
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        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMSACRINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>070867</drugauthorizationnumb>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
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        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
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      <drug>
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        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
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        <medicinalproduct>PEGASPARGASE</medicinalproduct>
        <drugindication>T-CELL TYPE ACUTE LEUKAEMIA</drugindication>
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      <drug>
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        <medicinalproduct>ANTITHYMOCYTE GLOBULIN</medicinalproduct>
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      <drug>
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      <drug>
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    <receiver></receiver>
    <patient>
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      <patientsex>1</patientsex>
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        <patientdeathdate></patientdeathdate>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG 1/2 TABLET TWO TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-07P-009-0422741-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO RETARD TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOLEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOLEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOLEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0423246-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BULIMIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027062</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR /00802602/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8025725</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>250 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE2007-0027</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>77095</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE2007-0026</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>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77031</drugauthorizationnumb>
        <drugdosagetext>UP TO 3TABS DAILY - PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-529010</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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-528730</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>ROUTE: DERMAL. GIVEN 25 MCS, CHANGED EVERY THIRD DAY.</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>GIVEN TWO TABLETS AT NIGHT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>GIVEN 6-8 TABLETS PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-528393</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-528758</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-528727</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>119.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-522824</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>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugauthorizationnumb>019645</drugauthorizationnumb>
        <drugdosagetext>A SYRINGE AND 3 EMPTY 30MG VIALS OF KETOROLAC WERE FOUND NEAR THE BODY AND THERE WAS A FRESH NEEDLE+</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510184-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US241675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>D058173</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-525343</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>20766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510186-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE2007-0028</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77031</drugauthorizationnumb>
        <drugdosagetext>20MG - DAILY - PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEKSTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-529370</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-447169</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528694</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>
      <patientweight>103.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugauthorizationnumb>21304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VALGANCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugdosagetext>GIVEN DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VALGANCICLOVIR</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugdosagetext>GIVEN DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>GIVEN FIVE DOSES.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>2149310_-03247</drugbatchnumb>
        <drugdosagetext>1 PILL BY MOUTH 2 X DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>100 MG 1 TIME PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006S1000212</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>0.87</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRIC OXIDE</medicinalproduct>
        <drugbatchnumb>2883</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM;CONT;INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRIC OXIDE</medicinalproduct>
        <drugbatchnumb>2883</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>5 PPM;CONT;INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD CELLS, PACKED HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>5 MG TWICE DAILY</drugdosagetext>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12217</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>105 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-528456</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-527830</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS 1-14 OF EVERY THREE WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS 1-14 OF EVERY THREE WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAY ONE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN C</medicinalproduct>
        <drugdosagetext>AS PER PROTOCOL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>GIVEN EVERY EVENING.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-476646</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>2 TIMES PER DAY FROM DAY 1 TO DAY 14, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>2 TIMES PER DAY, FROM DAY 1 TO DAY 14, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-431958</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOGT-KOYANAGI-HARADA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-523442</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK247849</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-UK241420</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>007413</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITENE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPARGRISEOVIT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710007573</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <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>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007165</companynumb>
    <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>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341621</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>FOOT FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200611001243</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>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1760 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>44 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*RITUXIMAB</medicinalproduct>
        <drugdosagetext>660 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>6 MG, OTHER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, OTHER</drugdosagetext>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>10 MG AT NIGHT</drugdosagetext>
        <drugindication>SEDATIVE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPANOL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710004165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312114</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFLAVONOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D AND ANGELIQ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>ONCE A WEEK INTRA-ARTER</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709004104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACETABULUM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOGENESIS IMPERFECTA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200708000183</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC /01263201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KADN20070103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007075</companynumb>
    <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>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A324158</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710006531</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugauthorizationnumb>21773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXENATIDE</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>1416</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2000 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710007364</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>KNEE ARTHROPLASTY</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>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC                           /01263201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>100 MG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXON</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PREPARATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugdosagetext>340 MG/KG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707004473</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>70.295</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003197</companynumb>
    <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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312114</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200709000135</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>740 MG, OTHER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>110 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</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>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugdosagetext>2 G, AS NEEDED</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1.2 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK250243</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>11.3399</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFANT TYLENOL</medicinalproduct>
        <drugdosagetext>1.6 ML</drugdosagetext>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>124.7392</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DON''T REMEMBER AS PRESCRIBED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugdosagetext>25MG DAILY 21D/28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL EYE DROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0062C-A</drugbatchnumb>
        <drugdosagetext>25MG DAILY 21D/28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-429993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO/OVRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-IND-05721-01</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICYCLIC ANTIDEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510225-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-UKI-02929-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510226-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430012N07JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>7 MG/M2, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>200 MG/M2, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS BIFIDUS, LYOPHILIZED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE /00028601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-400500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN 1/35-21</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</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>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH AND FORMULATION AND DOSAGE REGIMEN REPORTED AS 40 MG/20MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMOSONE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMPEX</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467348</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>54.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473383</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-526922</companynumb>
    <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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>TAKEN ON A WEEKLY BASIS.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>TAKEN ON A MONTHLY BASIS.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-527517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>MISSED 2 WEEKS OF TREATMENT AND NOW IN WEEK 6 OF TREATMENT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>MISSED 2 WEEKS OF TREATMENT AND NOW IN WEEK 6 OF TREATMENT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528585</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-511534</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS 'SERAQUEL' AND THE DOSE WAS INCREASED ON AN UNSPECIFIED DATE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-512923</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>90.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528472</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510237-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528570</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-485883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-21</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-462575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS SALMONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430011N07JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOCITABINE (ENOCITABINE)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B /00106601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE /00032601/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430008E07ITA</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>12 MG</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN)</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>170 MG</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR (ACICLOVIR /00587301/)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230207K07BRA</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS ; 22 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS ; 22 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-509844</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>020438</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED AS ORAL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>020438</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED AS ^VIA FEEDING TUBE.^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>020438</drugauthorizationnumb>
        <drugdosagetext>ROUTE REPORTED AS ORAL.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESANOID</medicinalproduct>
        <drugauthorizationnumb>020438</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 50 MG TWICE PER DAY, 2 WEEKS ON AND 2 WEEKS OFF.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugdosagetext>REPORTED AS ^FOUR DAYS OF INTRAVENOUS CHEMOTHERAPY.^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027685</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>33754</drugbatchnumb>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528788</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01543</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19452</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILDIEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510248-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510249-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510250-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25394</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#8#2007-00273</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>21589</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANTROLENE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418667-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER PALPABLE SUBCOSTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>484499A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>484499A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19720101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>7.5/750 MG TABS</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007230</companynumb>
    <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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341152</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007166</companynumb>
    <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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007214</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312638</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR HOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312638</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01037407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACINETOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>MULTIPLE-DRUG RESISTANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0611USA01792</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510263-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0709FRA00010</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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTAZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE AND FORMOTEROL FUMARATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510264-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05058</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>1571</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL D</medicinalproduct>
        <drugadministrationroute>065</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>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA05644</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>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0701USA03375</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL TINEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>020685</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0606USA03852</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2575</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
        <drugtreatmentduration>480</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19720101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-528396</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS INTERMITTENTLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS INTERMITTENTLY.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOSINE ARABINOSIDE</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS INTERMITTENTLY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-528213</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 20 MG IN ALTERNATE DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL DECONGESTANT NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS ANTI-ACNE SOAP.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS ALBA LOTION.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008666</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0706011</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007AC02112</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18732</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>78.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25 MG - 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</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>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25 MG - 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</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>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5 MG - 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLIGHT OF IDEAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101693</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>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>PEA045</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>PEA045</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041001991</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071004147</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20071006706</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>FOR 2 YEARS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20071007591</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>20588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RUBIFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101550</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>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070902363</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEARNING DISABILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H01038607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE</medicinalproduct>
        <drugauthorizationnumb>21821</drugauthorizationnumb>
        <drugdosagetext>100 MG STAT, THEN 50 MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACINETOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGECYCLINE</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugindication>MULTIPLE-DRUG RESISTANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-WYE-H01038507</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCALCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0422803-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5 OR 10MG, 1 OR 2 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25472</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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>200MG AM; 200MG NOON; 600MG HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2007PK02288</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN SUBMITE</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-ENATEC</medicinalproduct>
        <drugdosagetext>20/12.5 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008629</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0705024</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMLOBETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423305-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0422798-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DYSHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROATE OF SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>LIBIDO DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510315-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0418386-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007074617</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2007090977</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0419606-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</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>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-07P-114-0422827-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO THE MEDIASTINUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0420995-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0416442-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:12MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0375678-00</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OPPORTUNISTIC INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC RESPIRATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HYDROCHLORIDE HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC RESPIRATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029865</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-07P-008-0414974-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO HCT 300 MG/12.5 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN PG 62.5 MICROGRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIGNOCAINE 0.5% OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIFIL TEARS 1.4%</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL PUMPSPRAY 400 MICROGRAM/DOSE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON 10 MG TABLET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT 7.5 MG TABLET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MDI 250/25 250MCG-25MCG/DOSE INHALER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZE 10 MG TABLET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADEINE FORTE 500 MG/30 MG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-07P-161-0378416-00</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>67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0421046-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0414920-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.995</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0369443-00</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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN-TANNIN COMPLEX</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090716</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007066543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOSYM FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008645</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0708014</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>07H05047</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEVIT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007045714</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.545</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>011909</drugauthorizationnumb>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>011909</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>011909</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007021373</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME PENTAHYDRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091971</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCORD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007042925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UBIQUINONE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007052662</companynumb>
    <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1000MG</drugdosagetext>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510360-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007084537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007092495</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091217</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>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL250453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>21540</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006153166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US251206</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50MG, FREQUENCY NOT STATED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006153160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>165.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007019343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX244867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P084219</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANSAID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007010381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US251213</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>TUBERCULOSIS OF EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006153709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2003164414US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:250MG/M2-FREQ:CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:750MG/M2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2003156263US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:324MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:720MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:720MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:4320MG-FREQ:CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007073444</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007070970</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>TEXT:10MG/5ML ONE 5ML TEASPOONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007072188</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINAMIN F</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONSTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007AC02120</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>NERVE BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ASYSTOLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugadministrationroute>034</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRENALINE</medicinalproduct>
        <drugadministrationroute>034</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>PCA</drugdosagetext>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007083489</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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510384-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245823</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 MG, 1/MONTH</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 A?G, UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068753</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugauthorizationnumb>021150</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-07P-007-0422977-00</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510387-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0422781-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2007BH004222</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007064660</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245823</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 MG, 1/MONTH</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 A?G, UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007046818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510392-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250764</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>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG/KG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070906018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071100466</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510396-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-PFIZER INC-2007057591</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>RECTAL ATRESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050778</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13970405</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>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>CYC-1:400MG/M2 OVER 2 HOURS ON DAY 1. 250MG/M2 OVER 1 HOUR ON DAY 8.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV OVER 120 MIN ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV PUSH ON DAY 1 FOLLOWED BY 2400 MG/M2 CIV OVER 46-48 HRS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2 IV OVER 120 MIN ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BRISTOL-MYERS SQUIBB COMPANY-13955992</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13925037</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACRODERMATITIS ENTEROPATHICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZINC DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2007030656</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-H00974007</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007044691</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074966</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250748</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>816 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007071348</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>ALLODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007083240</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007081234</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TERATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTONORM</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRADER-WILLI SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTREVA</medicinalproduct>
        <drugdosagetext>FREQ:1.5 TAB/WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTREVA</medicinalproduct>
        <drugdosagetext>FREQ:1.5 TAB/WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007078294</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERLOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007079712</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250619</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.977</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B3070, B3138</drugbatchnumb>
        <drugdosagetext>1071 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-ACETYLDIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZANIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC COMPONENTS UNKNOWN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC COMPONENTS UNKNOWN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007077950</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007077770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>TEXT:5/50 MG. HALF TABLET DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugdosagetext>TEXT:1000 UNITS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIETHYLPROPION HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0423112-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-06P-056-0326143-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-06P-087-0354376-01</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</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>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
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        <drugenddate>20061205</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070111</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL FUNCTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <companynumb>DK-ABBOTT-07P-044-0419940-00</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
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        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007076209</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
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        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
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  <safetyreport>
    <safetyreportid>5510424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
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    <companynumb>US-PFIZER INC-2007076087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>90.909</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5510425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>25.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPIPHYSIOLYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.1 MG, 7/WEEK</drugdosagetext>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5510426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090703</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>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG-TEXT:TDD:50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
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        <drugenddate>20071017</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:400MG-TEXT:TDD:400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
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  <safetyreport>
    <safetyreportid>5510427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
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    <companynumb>GB-PFIZER INC-2007083804</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5510428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007091383</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>EPISTAXIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID TABLET</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICIZINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETAPIAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMPIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    <safetyreportid>5510429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>JP-PFIZER INC-2007091376</companynumb>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
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    <safetyreportid>5510431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>CA-PFIZER INC-2007092997</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>020779</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5510432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
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      <patientsex>2</patientsex>
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        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5510433-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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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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      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000715</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709000705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</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>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007377</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>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ELI_LILLY_AND_COMPANY-NO200709006339</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>N.A.</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANOLOL</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710007312</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISULFIRAM</medicinalproduct>
        <drugindication>ALCOHOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000196</companynumb>
    <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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A204815</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710007457</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</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>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710007465</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugdosagetext>18 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200711000294</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, 4/D</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE                          /00033401/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STERNAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510446-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ELI_LILLY_AND_COMPANY-AR200710006610</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>BLOOD BILIRUBIN UNCONJUGATED 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>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092452</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11044</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10857</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLOPPY IRIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007RR-11078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076386</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-RANBAXY-2007R1-11040</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC BASICS 50 MG MAGENSAFTRESISTENT</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN TABLETS BP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE TABLETS BP 40MG</medicinalproduct>
        <drugauthorizationnumb>078010</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENAZON-KOFFEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510454-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10189</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70469</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCINE RPG 25MG/2.5ML SOLUTION INJECTABLE</medicinalproduct>
        <drugdosagetext>8 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCINE RPG 25MG/2.5ML SOLUTION INJECTABLE</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCINE RANBAXY 250 MG COMPRIME PELLICULE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugdosagetext>2 DF, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugindication>CONDITION AGGRAVATED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510455-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCUFLOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091688</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRO</medicinalproduct>
        <drugbatchnumb>0582024</drugbatchnumb>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0417050-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTEMIC GLUCOCORTICOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0420173-00</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>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091526</companynumb>
    <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>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugindication>PITUITARY TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091455</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.181</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510466-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAXTER-2007BH008232</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C VIRUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03B13A014</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03G21A061</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03C24A027</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03102A079</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03A14A001</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03B12A013</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03H05A068</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMOFIL M</medicinalproduct>
        <drugbatchnumb>03G28A066</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA VH IMMUNO</medicinalproduct>
        <drugbatchnumb>05A3702H</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA VH IMMUNO</medicinalproduct>
        <drugbatchnumb>05A3503F</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA VH IMMUNO</medicinalproduct>
        <drugbatchnumb>05A4303I</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA VH IMMUNO</medicinalproduct>
        <drugbatchnumb>05A3703F</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTHROMPLEX TOTAL S-TIM4</medicinalproduct>
        <drugbatchnumb>05CH1303I</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-250301</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091465</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250296</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500 A?G, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOLICIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN LACTOBIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091426</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2007091391</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510473-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-248817</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG, Q15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, UNK</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1040 MG, UNK</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028537</companynumb>
    <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007RR-11094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>076134</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-248067</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-247530</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-244779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.959</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>252 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200712482DE</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAL CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510487-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250550</companynumb>
    <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 FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510492-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P082155</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US251314</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5MG FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVREDOL</medicinalproduct>
        <drugdosagetext>1 DOSE EVERY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423193-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ABBOTT-07P-044-0422825-00</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugdosagetext>180MG/2MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HJERDYL</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423404-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICARE D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-07P-083-0421156-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 TRIGLYCERIDES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US251383</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG LYOPHILIZED (FREQUENCY UNKNOWN)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG PREFILLED SYRINGE (FREQUENCY UNKNOWN)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510503-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250808</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>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033575</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>126.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPHTHALMIC FLUID DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9784A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>25 NG, 1X/DAY</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, 1X/DAY</drugdosagetext>
        <drugindication>DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>300 MG/D, UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugdosagetext>50 MG/D, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG/D, UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>2 MG/D, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>5 MG/D, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510505-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-021754</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT HOME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4598A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
        <drugtreatmentduration>1501</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510506-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018712</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>67.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4601A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>1DROP, 2X/DAY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, 5X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>10 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510507-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US241912</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL GANGLION DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>L006474</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC PNEUMONIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFIBROTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRILAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510508-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510509-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-040363</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>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA2760A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510510-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-014623</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>104.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VA6810A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>651</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, BED T.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510511-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US248888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510512-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-034201</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>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA8746A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-040202</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>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, 1X/DAY</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>4 MG/KG, 1X/DAY</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510514-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-030894</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-037294</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>
      <patientweight>53.968</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugdosagetext>3MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400MG/3XDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510516-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250097</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BK VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510521-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510522-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANENCEPHALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-DE-06457GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>THREE 5% PATCHES WORN 12 HOURS ON, 12 HOURS OFF TO AFFECTED AREAS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510524-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US246558</companynumb>
    <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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US247350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510529-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422907-00</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0422860-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510531-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423306-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>A.P.C.</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250227</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DF, SINGLE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-249852</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>575</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200708006604</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>8 IU, 3/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMACART NPH</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>8 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200710007615</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>20-30 IU PREMEALS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>24 U, EACH MORNING PREBREAKFAST</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>26 U, PRELUNCH</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>28 U, EACH EVENING PREMEAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>20 U, EACH MORNING PREBREAKFAST</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>20 U, PRELUNCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>27 U, EACH EVENING PREMEAL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>26 U, EACH EVENING BEFORE BED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETIC KETOACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>32 U, EACH EVENING PREBED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>30 U, EACH EVENING PREBED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007525</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200709004637</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>5 U, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510541-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708004694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A268862</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510542-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000209</companynumb>
    <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>BYETTA</medicinalproduct>
        <drugbatchnumb>A302400</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708004006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A308356</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000087</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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLIOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A357808</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 U, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A357808</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>24 U, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A344555</drugbatchnumb>
        <drugdosagetext>16 U, EACH MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A344555</drugbatchnumb>
        <drugdosagetext>24 U, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTIN</medicinalproduct>
        <drugdosagetext>40 UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007393</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711001595</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000642</companynumb>
    <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007400</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIABETICS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710006488</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510552-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006986</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510553-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710007181</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711000298</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IMPAIRED INSULIN SECRETION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002034</companynumb>
    <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 FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>20 MG, EACH MORNING</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELATESTRYL</medicinalproduct>
        <drugdosagetext>100 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>10 MG, EACH MORNING</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>0.2 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>0.2 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A309432</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709002671</companynumb>
    <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007431</companynumb>
    <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>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A324159</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709003527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A334512</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 4/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-ABBOTT-07P-022-0419592-00</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL 10MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-07P-143-0422064-00</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>2</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLACEE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422941-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</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>5510566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-250887</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG/M2, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE (BLINDED)</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510568-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BK VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugdosagetext>20 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugdosagetext>20 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR:  GENZYME</medicinalproduct>
        <drugdosagetext>20 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugdosagetext>20 MG/M2 QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2 QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>440 MG/M2 QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>460 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>460 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>440 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>440 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE-SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-250771</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.574</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>340 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNOMYCIN</medicinalproduct>
        <drugdosagetext>78 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME).  MFR:  GEN</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME). MFR:  GENZ</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLY-VI-SOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-ALANINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESIDUAL URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME). MFR: GENZY</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHA-GLUCOSIDASE (HUMAN, RECOMBINANT, CHO CELLS, GENZYME). MFR: GENZY</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID. MFR: TAP PHARMACEUTICALS INC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLY-VI-SOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX. MFR: BRAINTREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CULTURELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN. MFR: HOFFMAN-LA ROCHE, INC.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007PO0160</companynumb>
    <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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071004-0001056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEMBUTAL</medicinalproduct>
        <drugbatchnumb>50984Z721</drugbatchnumb>
        <drugauthorizationnumb>83246</drugauthorizationnumb>
        <drugdosagetext>40 MG;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>1 MG;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009372</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugauthorizationnumb>74587</drugauthorizationnumb>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250604</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>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, UNK</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006413</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>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>15 U, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>80 U, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>70 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711000305</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A251697</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006399</companynumb>
    <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>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A257282</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>18 U, DAILY (1/D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711001044</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IMPAIRED INSULIN SECRETION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711001191</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000524</companynumb>
    <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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002753</companynumb>
    <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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A282987</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A303661</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>A191276</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PH BODY FLUID ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
        <drugauthorizationnumb>21947</drugauthorizationnumb>
        <drugdosagetext>600 UG PRN BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTORA</medicinalproduct>
        <drugauthorizationnumb>21947</drugauthorizationnumb>
        <drugdosagetext>600 UG PRN BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238427K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAT TISSUE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510589-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-07P-217-0421566-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>379926200068</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKTIFERRIN COMPOSITUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKTIFERRIN COMPOSITUM</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOMACK DEPOT</medicinalproduct>
        <drugindication>VASODILATATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP 10</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-07P-008-0376331-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE W/LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugindication>BLOOD PROLACTIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIQUIMOD</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS TURBUHALER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238325K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; 44 MCG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; 44 MCG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239340K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238001K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.7705</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANASTOMOTIC ULCER HAEMORRHAGE</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 SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS, 44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS, 44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, 2 IN 1 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>236773K06USA</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS, 44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS, 44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12333</companynumb>
    <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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>150 MG; EVERY MORNING, ORAL, 300 MG; AT BEDTIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>150 MG; EVERY MORNING, ORAL, 300 MG; AT BEDTIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1008590</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>86009</drugauthorizationnumb>
        <drugdosagetext>25 MG; DAILY; ORAL, 50 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>86009</drugauthorizationnumb>
        <drugdosagetext>25 MG; DAILY; ORAL, 50 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07040373</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 HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY X28 DAYS, ORAL, 200 - 400MG, DAILY X28 DAYS, ORAL, 200 MG, DAILY X28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY X28 DAYS, ORAL, 200 - 400MG, DAILY X28 DAYS, ORAL, 200 MG, DAILY X28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY X28 DAYS, ORAL, 200 - 400MG, DAILY X28 DAYS, ORAL, 200 MG, DAILY X28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07030671</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06495GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06494GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06493GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-13969BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>BEREAVEMENT REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/2/DAY</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PHOBIA OF FLYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELESTROGEN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELESTROGEN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELESTROGEN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELESTROGEN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELASIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCIN / ORA PST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-ESTRADIOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>EPICONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>EPICONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOBETASOL PROPIONATE OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07091425</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>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06482GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-CN-00770CN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23465BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23365BP</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</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>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23997BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23555BP</companynumb>
    <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21613BP</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>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21692BP</companynumb>
    <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>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</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <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</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17331BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DANDY-WALKER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINGLE UMBILICAL ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-01383NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06535GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06492GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</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>FUNGUS SPUTUM TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06480GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07050023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>5MG FOR 7DAYS, 10MG FOR 7 DAYS, 15MG FOR 7 DAYS, AND 20MG FOR 7 DAYS, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23519BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06262DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHONESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELIOSIS HEPATIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVUM</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reaction>
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    <patient>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23995BP</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23984BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703709A,7C2218</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23557BP</companynumb>
    <primarysource>
      <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>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06499GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEM XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5510640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-04590BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
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        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510641-6</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030912</drugstartdate>
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        <drugenddate>20040323</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071108</receivedate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
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        <drugenddate>20050708</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASPIRIN CALCIUM</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510644-1</safetyreportid>
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      <reportercountry>UGANDA</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
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        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
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        <drugstartdate>20060811</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510647-7</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>060425W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23684BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23682BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23685BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23683BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08768BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>602485,5C2214</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-08321BP</companynumb>
    <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>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>508689A,509935,601932,5C2200</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20108BP</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070181W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070181W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06432DE</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL 0,18 MG</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21553BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703046A,7C1210</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21757BP</companynumb>
    <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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>070346W</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22927BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765044A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0665242A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7E08</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688232A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
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      <reaction>
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        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <reportercountry>UNITED STATES</reportercountry>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.5 UNK, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430085K07USA</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>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>12 MG/M2, ONCE, INTRAVENOUS (NOT OTHERWISE SPECIFIED); 5 MG/M2, INTRAVENOUS (NOT OTHERWISE SPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>12 MG/M2, ONCE, INTRAVENOUS (NOT OTHERWISE SPECIFIED); 5 MG/M2, INTRAVENOUS (NOT OTHERWISE SPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250721</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>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EYCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>UNSPECIFIED ON AN EVERYDAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11351</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>41.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER CHEWABLE TABLET ORANGE (NCH) (GUAR GUM) CHEWABLE TABLET</medicinalproduct>
        <drugbatchnumb>10020080</drugbatchnumb>
        <drugdosagetext>1-3 TABS EACH DAY, ORAL; 3 DF, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER CHEWABLE TABLET ORANGE (NCH) (GUAR GUM) CHEWABLE TABLET</medicinalproduct>
        <drugbatchnumb>10020080</drugbatchnumb>
        <drugdosagetext>1-3 TABS EACH DAY, ORAL; 3 DF, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR/NET (ATORVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS (DRUG THERAPY NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493521A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL + PSEUDOEPHEDRINE (FORMULATION UKNOWN) GENE (ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBINOXAMINE + DEXTROMET (FORMULATION UNKNOWN) (CARBINOXMINE + DEXTRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-250662</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>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>450 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>282 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>560 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>4 G, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0460366A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL + PSEUDOEPHEDRINE (FORMULATION UNKNOWN) (GENE (ACETAMINOPH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HBR (FORMULATIO9N UNKNOWN) (DEXTROMETHORPHAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYLAMINE (FORMULATION UNKNOWN) (DOXYLAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENC200700182</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>77.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>20883</drugauthorizationnumb>
        <drugdosagetext>2 MCG/KG/MIN, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, Q 12 HRS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL /00139501/ (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE (DOCUSATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA /0142201/ (SENNA ALEXANDRINA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRDNISONE (PREDNISONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE (METOCLOPRAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX /00082501/ (ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007PV033625</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugauthorizationnumb>21332</drugauthorizationnumb>
        <drugdosagetext>120 MCG;TID;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000577</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VESSEL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASAN</medicinalproduct>
        <drugauthorizationnumb>75252</drugauthorizationnumb>
        <drugdosagetext>50 MG;QD;</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLAZAL</medicinalproduct>
        <drugdosagetext>2.25 GM;TID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAL DEFENSE (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE (CON.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE /0072801/ (CON.)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-250353</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMATIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 DF, Q4W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRYSTALLINE ZINC INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110077</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11199</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>88.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU VAPOR PATCH (NCH) (EUCALYPTUS OIL, CAMPHOR, MENTOL) PATCH</medicinalproduct>
        <drugbatchnumb>10036833</drugbatchnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11151</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MINIMAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VESSEL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROULEAUX FORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, Q6H FOR 3 OR 4 DOSES, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN, DEXTROMETHORPHAN, PSEUDOEPHEDRINE</medicinalproduct>
        <drugdosagetext>ONCE/SINGLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250765</companynumb>
    <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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250703</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11554</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP (NCH) (HYOSCINE HYDROBROMIBE) TRANS-THERAPEUTIC-SYSTEM</medicinalproduct>
        <drugauthorizationnumb>17874</drugauthorizationnumb>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US08008</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>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>960 MG, QD FOR 2 DAYS, ORAL; 640 MG, QD FOR 2 DAYS, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>960 MG, QD FOR 2 DAYS, ORAL; 640 MG, QD FOR 2 DAYS, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>960 MG, QD FOR 2 DAYS, ORAL; 640 MG, QD FOR 2 DAYS, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0625668A</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>77.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0640663A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANDROGEN DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTISM SPECTRUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL TESTICLE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0656852A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0665900A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYCHOTROPIC MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0674723A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugbatchnumb>07C098P</drugbatchnumb>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL PATCHES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0679703A</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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugauthorizationnumb>050785</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681861A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>7ZP9838</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682849A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689592A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689850A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690547A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690625A</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>70.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R295578</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691047A</companynumb>
    <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 SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691088A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAMPOO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCACORTEN VIOFORM EARDROPS</medicinalproduct>
        <drugdosagetext>2DROP THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>001</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600MG AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5MG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691245A</companynumb>
    <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 BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691251A</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>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691261A</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691262A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</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>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>352</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL REDUCING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691432A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691451A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTRIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691702A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691734A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692303A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692310A</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>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHALATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>70020</drugbatchnumb>
        <drugauthorizationnumb>20121</drugauthorizationnumb>
        <drugdosagetext>4SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693016A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693021A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693025A</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693026A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693027A</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693028A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693029A</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693030A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693031A</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693032A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693033A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693048A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693049A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693050A</companynumb>
    <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>INJURY</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693054A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>020518</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693061A</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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>300MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0381764A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATISATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFADAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0409631A</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>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051015</drugenddate>
        <drugtreatmentduration>746</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>3.75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0452420A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOEXIPRIL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0462872A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOMIDATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0483650A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070121</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAXODI</medicinalproduct>
        <drugdosagetext>11400IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINI-SINTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0483793A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATECHOLAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486676A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487392A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487650A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</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>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>050754</drugauthorizationnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489342B</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489535A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489699A</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490005A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>9.2</patientweight>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>18603</drugauthorizationnumb>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ORAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTAX</medicinalproduct>
        <drugdosagetext>.3G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GINGIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.3</medicinalproduct>
        <drugdosagetext>1000ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491049A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>050542</drugauthorizationnumb>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491221A</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>4000IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
        <drugdosagetext>4500IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>225MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugdosagetext>4SAC PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUCOX</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON B9</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491331A</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>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</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>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEONECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEONECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491444A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELENZA</medicinalproduct>
        <drugauthorizationnumb>021036</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISPORAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491760A</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492261A</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492684A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492816A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1850MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>15MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>37MCG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492870A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492872A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCOBAL</medicinalproduct>
        <drugdosagetext>1000MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>958</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493170A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>35MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM + VALPROIC ACID</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493280A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>35MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SABRIL</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMISUCCINATE D'HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493387A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULTANOL</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493583A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>380MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493720A</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>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</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>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493723A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONSTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493726A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>21003</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493728A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HYPERMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493732A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</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>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>12MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON N</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493734A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>P0709023</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>375MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493886A</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>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5G PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493896A</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>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493902A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493974A</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494040A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494187A</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>705MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMODIALYSIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007US01532</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUCKLEY'S MIXTURE (USA) (NCH) (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP</medicinalproduct>
        <drugbatchnumb>4E30017</drugbatchnumb>
        <drugdosagetext>0.5 TSP, ONCE/SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494297A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494323A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494378A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>1.6MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAROPENEM SODIUM</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494473A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INHALATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>DT2/1863</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494488A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054980A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28.123</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE (UNSPECIFIED) (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugdosagetext>UNSPECIFIED EVERY NIGHT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL PLAQUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COOL MINT LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugbatchnumb>03117L</drugbatchnumb>
        <drugdosagetext>5 OR 6 IMES DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, SPECIFIED (DRUG, SPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007332573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S SUDAFED PE COLD + COUGH (DEXTROMETHORPHAN, PHENYLEPHRINE)</medicinalproduct>
        <drugbatchnumb>0ADRK</drugbatchnumb>
        <drugdosagetext>5 ML, 4 DOSES, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GENENTECH-250576</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>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B3137</drugbatchnumb>
        <drugdosagetext>280 MG, QOW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>200 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>160 MG, 1/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>820 MG, 1/WEEK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>650 MG, 1/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>33 MG, 1/WEEK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>P538202</drugbatchnumb>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>M92082</drugbatchnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>1848001</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>156418</drugbatchnumb>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HIGH FREQUENCY ABLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711927US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugdosagetext>50 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30797_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.2345</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>(2.5 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>(15 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>(10 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>(2.5 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE                  (UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE                (UNKNOWN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN                             (UNKNOWN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX002574</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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ASYSTOLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugauthorizationnumb>9829</drugauthorizationnumb>
        <drugdosagetext>60 MG;QID</drugdosagetext>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_00964_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</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>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>77456</drugauthorizationnumb>
        <drugdosagetext>(1200 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>(DF SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_01000_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.2762</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN PLATELET VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>77456</drugauthorizationnumb>
        <drugdosagetext>(600 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>(150 MCG/0.5 ML 1X/WEEK SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>METFORMIN HCL</medicinalproduct>
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        <drugdosagetext>500 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
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        <drugstartdate>20070801</drugstartdate>
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        <drugenddate>20070912</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510801-4</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20051229</receiptdate>
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      <reportercountry>PERU</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL BACTERAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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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>
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    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022963</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>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022966</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>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022962</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>CONDITION AGGRAVATED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510807-5</safetyreportid>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022892</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>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISCHARGE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
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        <drugenddate>20030801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32027</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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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>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>19971001</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510809-9</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
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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>36</patientonsetage>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20040113</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510810-5</safetyreportid>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</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>
      <patientonsetage>36</patientonsetage>
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      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20061110</drugstartdate>
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        <drugenddate>20071001</drugenddate>
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  <safetyreport>
    <safetyreportid>5510811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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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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      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20050601</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510812-9</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>IDIOPATHIC URTICARIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>URTICARIA CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32001</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01652</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA04065</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA00918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060702</drugenddate>
        <drugtreatmentduration>327</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510817-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022884</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>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA00454</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00791</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>19510</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </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>ELASPOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA02542</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>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0702USA04765</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01651</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA05402</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00913</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0709USA02057</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>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA01226</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA03728</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060829</drugenddate>
        <drugtreatmentduration>2025</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0601USA01862</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>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022901</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>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0608USA05352</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>143</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUSTER HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
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        <drugstartdate>20000101</drugstartdate>
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      <drug>
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        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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      <drug>
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        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20010101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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      <drug>
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        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
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        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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    <safetyreportid>5510831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20071107</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20050101</drugstartdate>
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        <drugenddate>20060501</drugenddate>
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    <safetyreportid>5510832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
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      <drug>
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        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
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      <drug>
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        <drugstartdate>20070721</drugstartdate>
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      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
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        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
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        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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    <safetyreportid>5510835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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        <drugstartdate>20060622</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>SEPTRIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>VITACAP</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
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        <drugenddate>20070614</drugenddate>
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    <safetyreportid>5510836-1</safetyreportid>
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    <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>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
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    <safetyreportid>5510837-3</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>45</patientonsetage>
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        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>20070529</drugstartdate>
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      <drug>
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        <medicinalproduct>COTRIM</medicinalproduct>
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      <drug>
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        <medicinalproduct>PYRIMETHAMINE</medicinalproduct>
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        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
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    <safetyreportid>5510838-5</safetyreportid>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
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        <medicinalproduct>BISACODYL</medicinalproduct>
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      <reportercountry>UNITED STATES</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
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      <drug>
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        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20060601</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022683</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>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
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      <drug>
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        <medicinalproduct>AVONEX</medicinalproduct>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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      <drug>
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        <medicinalproduct>AVONEX</medicinalproduct>
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        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022703</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>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>WOUND</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022850</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>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>32021</drugbatchnumb>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002637</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050404</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002636</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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002459</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>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200 G,</drugdosagetext>
        <drugindication>PNEUMONIA CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/COLECALCIFEROL (COLECALCIFEROL, CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugdosagetext>150 MG FREQ UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>450 MG FREQ UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONXOL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313382-00</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>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
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        <drugdosagetext>250 ML, TWICE,</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION (BLOOD TRANSFUSION, AUXILIARY PRODUCTS)</medicinalproduct>
        <drugdosagetext>250 ML, TWICE</drugdosagetext>
        <drugindication>TRANSFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <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>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44, OTHER, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE(MINOCYCLINE HYDROCHLORIDE)</medicinalproduct>
        <drugindication>SWEAT GLAND INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163388USA</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>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>76277</drugauthorizationnumb>
        <drugdosagetext>1200 MG (1200 MG, 1 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>25.7143 MCG (180 MCG, 1 IN 1 WK)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022153</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>140 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <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>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000199</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>100.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>6GR040-05</drugbatchnumb>
        <drugauthorizationnumb>20845</drugauthorizationnumb>
        <drugdosagetext>40 PPM; CONT; INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>VENTRICULAR ASSIST DEVICE INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE ^SIOTIKA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021905</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>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON (PEGINTERFERON ALFA-2B)SC</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022053</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002625</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>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER INFECTION NEUROLOGICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>5 M, BID; 4 MG, BID; 1MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)(ANTITHYMOCYTE IMMUNOGLOBULIN (RA</medicinalproduct>
        <drugdosagetext>150</drugdosagetext>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETOPRIM + SULFAMETOXAZOL (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002176</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>8 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002324</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>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, BID, ORAL; 2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, BID, ORAL; 2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>120 MG, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM (TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACL (SODIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUMEDROL OR PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE (HYDRALAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001726</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>101.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>KIDNEY TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021825</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BASOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTEROL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68023</drugbatchnumb>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021427</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>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313397-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUCHENNE MUSCULAR DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>19115</drugauthorizationnumb>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM (ROCURONIUM)</medicinalproduct>
        <drugindication>INTUBATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV HYPERALIMENTATION (SOLUTIONS FOR PARENTERAL NUTRITION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLYTELY (GOLYTELY /00747901/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENEMA (ENAMAS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S SOLUTION (RINGER-LACTATE /01126301/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5% ALBUMIN (ALBUMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL (PHENOBARBITAL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN / TAZOBACTAM (PIP / TAZO)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00462</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>102.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>66.00 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE (FAMOTIDINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT HFA (IPRATROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY:QD, ORAL; 20 MG, 1X/DAY:QD, ORAL; 30 MG, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY:QD, ORAL; 20 MG, 1X/DAY:QD, ORAL; 30 MG, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY:QD, ORAL; 20 MG, 1X/DAY:QD, ORAL; 30 MG, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04696</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>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
        <drugdosagetext>10-20 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID (ALUMINIUM HYDROXIDE, DIMETHICONE, MAGNESIUM HYDROXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>008387</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>AMNIOCENTESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUBELLA ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40  MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN LO</medicinalproduct>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERVIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHITOSAN (POLIGLUSAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITA-PAK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017712</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI012337</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CNS VENTRICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI003234</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68015</drugbatchnumb>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021836</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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510875-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020386</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>56.6996</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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHICILLIN-RESISTANT STAPHYLOCOCCAL AUREUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018566</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>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510878-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017737</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>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY SATIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019464</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510880-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021254</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>HEPATIC ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32006</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2007-0013965</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROHEPARUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEIN SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM GLYCYRRHIZATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021089</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>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020513</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510884-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022798</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG QM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022902</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>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG QM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510886-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023117</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>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG QM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
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  <safetyreport>
    <safetyreportid>5510887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG QM IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5510888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041230</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016941</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>HYPERTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32016</drugbatchnumb>
        <drugdosagetext>30 UG; QW</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5510890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016597</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>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005BI013316</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>ARM AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT FIBROUS HISTIOCYTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5510892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163429</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>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510893-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020315</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>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010425</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510895-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019571</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023124</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>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32026</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510897-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023224</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>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5510898-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023328</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023179</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>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023068</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32024</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020094</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75389</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID,</drugdosagetext>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750 MG/M2, ON DAY 1, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB                      (RITUXIMAB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027703</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>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21872</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#2#2006-00255</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>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>4341201</drugbatchnumb>
        <drugauthorizationnumb>75410</drugauthorizationnumb>
        <drugdosagetext>20 MG,1 IN 1 D,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>4341201</drugbatchnumb>
        <drugauthorizationnumb>75410</drugauthorizationnumb>
        <drugdosagetext>20 MG,1 IN 1 D,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO; 325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO; 325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM                                                             </medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM                                                (MAGNESIUM)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITAXIMAB</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACHROME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^HERBAL REMEDY^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US17818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>85966</drugauthorizationnumb>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLINTANE                               (PROLINTANE)</medicinalproduct>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE                               (NICOTINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>C-07-0024</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>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE INTENSOL</medicinalproduct>
        <drugauthorizationnumb>88254</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AEUSA200700158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N8H11</drugbatchnumb>
        <drugdosagetext>25 GM; 1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VASCULITIS CEREBRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N8HJ1</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WSDF_00654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.9457</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO SDF</medicinalproduct>
        <drugbatchnumb>LOT 26006011</drugbatchnumb>
        <drugdosagetext>75 UG/KG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-LLY01-GB200607003154</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03300</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG DOSAGE FORM ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2007-03774</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>7 DAY 1 DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 2X PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACTIVITIES OF DAILY LIVING IMPAIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0105</drugbatchnumb>
        <drugdosagetext>1 MG 2 TIMES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG/ DAY 1, 500 MG/DAYS 2-5 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>65.318</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>B1035</drugbatchnumb>
        <drugdosagetext>150 MG MONTHLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG ? WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123.832</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL 40 MG WATSON</medicinalproduct>
        <drugdosagetext>40 MG 1X TIME DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.637</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0181</drugbatchnumb>
        <drugdosagetext>.5 MG 2XPD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>200 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510930-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
        <drugdosagetext>120 GM TWICE DAY TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>2 PUFFS AS NEEDED PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILDHOOD DISINTEGRATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>300 MGS AM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>300 MGS AM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>81.1939</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>TWO TO FOUR TABLES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>100 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>INJECT 3.75MG MONTHLY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>INJECT 1ML EVERY OTHER DAY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.4822</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGIBIND</medicinalproduct>
        <drugdosagetext>224MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIOACTIVE DRUG LEVEL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</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>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18524</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERCOSTAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007FR16631</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>
      <patientweight>63.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRINSIC VASCULAR COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20071007768</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-ASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007962</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 TO 20 MG PER WEEK SEP-2004 TO 20-AUG-2007, PAUSED DURING AN UNKNOWN SHORT PERIOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OYSTER SHELL CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN/HCT</medicinalproduct>
        <drugdosagetext>20MG/12.5 MG BEGINNING JUL-2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUTY ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>37.5/300 MG BEGINNING SEP-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071008011</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>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>5510962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.131</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CA14882</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILOTINIB</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP06659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US09631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>50 MCG PATCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>100 MCG PATCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP18249</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOTILLOMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>30-60 TABS/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX11776</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14475</companynumb>
    <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14442</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US10717</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>53.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLARY THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050426</drugenddate>
        <drugtreatmentduration>1184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>30 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US10712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.528</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOCYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</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>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050427</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUTY ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>630 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005AR15693</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>SCREENING PHASE</drugdosagetext>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATLANSIL</medicinalproduct>
        <drugindication>TACHYARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5510996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00506307</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC CAPILLARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHAMBERG'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP06659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-027055</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>.25 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>.5 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>.75 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>1 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGYNON 30 (21)</medicinalproduct>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10030</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011215</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB01903</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100MG MANE, 200MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT12475</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>30 MG/KG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-027733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-025115</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>
      <patientweight>2.422</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>1 ML, EVERY 2D</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061024</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>250 MG, 1X/WEEK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00965607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-WYE-H00700207</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISERCIN</medicinalproduct>
        <drugdosagetext>OVERDOSE AMOUNT UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00530307</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>255 MG (127 MG/M2) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>350 MG (175 MG/M2) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIDOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>400 MG (4.82 MG/KG) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3.4 G EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TYCO HEALTHCARE/MALLINCKRODT-T200701351</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE PAMOATE</medicinalproduct>
        <drugauthorizationnumb>17090</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE PAMOATE</medicinalproduct>
        <drugauthorizationnumb>017090</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101218</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>55.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>24599</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>24599</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PAIN</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101678</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>PHA207</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>PHA207</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>TWICE</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101700</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>72.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugdosagetext>POSSIBLY 10 CAPLETS AT A TIME ON OCCASION</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101240</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>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLANTA SUPREME TASTING CHERRY</medicinalproduct>
        <drugbatchnumb>PAF144</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071007022</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071004994</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904798</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>104.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFUR LOTION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLET</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007861</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706119</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706119</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0627738</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEAD INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEAD INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>KYPHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugindication>KYPHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0706112</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>90UG, 2 PUFFS FOUR TIMES DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10G/15ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>3X 150MG TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXY IR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100419</companynumb>
    <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>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>158.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAKTHROUGH PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugdosagetext>2X 25UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRAIN OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL WITH HYDROCHLORIAZIDE</medicinalproduct>
        <drugdosagetext>5MG/6.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071100042</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTALFEBAL BAMBINI  2 %</medicinalproduct>
        <drugauthorizationnumb>19842</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071007472</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LENTICULAR OPACITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEBORRHOEIC DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019927</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SEBORRHOEIC DERMATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED EYE DROPS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070504919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071007601</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19735</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGASTORO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060302705</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YONDELIS</medicinalproduct>
        <drugauthorizationnumb>50286</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200712367</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOGLOBULIN</medicinalproduct>
        <drugdosagetext>5 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD IMMUNOGLOBULIN G DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-11576</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>10.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINE TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER AND PANCREAS TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>20 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTESTINAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>20 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>20 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>2 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTESTINE TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>2 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH161-01</drugbatchnumb>
        <drugdosagetext>2 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREAS TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>6.5 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTESTINE TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>6.5 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>6.5 MG/KG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREAS TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPOTERICIN B LIPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422967-00</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>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713521BCC</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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRONKAID</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 50 MG  UNIT DOSE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0680</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugdosagetext>IV NOTSPEC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTERIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GINGIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULBACTAM SODIUM-AMPICILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0677</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITICOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYCARBOPHIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANYTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACIDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-TYCO HEALTHCARE/MALLINCKRODT-T200701352</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>020631</drugauthorizationnumb>
        <drugdosagetext>.4 MG, SINGLE</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>020631</drugauthorizationnumb>
        <drugdosagetext>3 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>020631</drugauthorizationnumb>
        <drugdosagetext>4 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>020631</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, Q6H PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
        <drugdosagetext>0.25 UG/KG/MIN</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
        <drugdosagetext>0.07-0.25 UG/KG/MIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE14322</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG EVERY 3-4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
        <drugtreatmentduration>974</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRA-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP14581</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY INTESTINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUNNER'S GLAND HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY UPPER GASTROINTESTINAL TRACT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBMANDIBULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOID CYSTIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBALS NOS W/VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0604</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#08#2007-04327</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>71479</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 - 1 MG/DAY; STOPPED (3 WEEKS LATER)</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERON (MELPERONE) (MELPERON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00407607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTIDEPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE (8.9 MCG/ML)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>7.5 MG FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001#1#2007-00671</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04283</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>RUBELLA ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77299</drugauthorizationnumb>
        <drugdosagetext>50MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13948153</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13794938</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=CAPSULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=POWDER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOFEED</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIKELAN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=EED</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=EED</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM=TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE DISCHARGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-1199211020</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>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOMIDATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROM.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200610183GDS</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 30 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 750 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13972054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6039105</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>8 IU (8 IU, 1 D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060204</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC (ACETYLSALICYLIC LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04370</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>77299</drugauthorizationnumb>
        <drugdosagetext>50 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>77299</drugauthorizationnumb>
        <drugdosagetext>50 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE (CODEINE) (CODEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04317</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77232</drugauthorizationnumb>
        <drugdosagetext>20MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN) (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE (CODEINE) (CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL (PARAMOL-118) (DIHYDROCODEINE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC) (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL (PLANTAGO OVATA) (ISPAGHULA HUSK)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA ALENXANDRINA) (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL) (SILDENAFIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071007868</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>
      <patientweight>66.5</patientweight>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>7CD7101301</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071007905</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1-15470401</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM CHELONEI INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>40189</drugauthorizationnumb>
        <drugdosagetext>4MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-USA-05267-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXCESSIVE EYE BLINKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>OBSESSIVE THOUGHTS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>TIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02736</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>865</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3 MITE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NL17420</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRAX</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1000 UG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES17428</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15535</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03189</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STENOCRAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCOGANT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-200716366GDS</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>629</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09233</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>77766</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09241</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (NGX)(METFORMIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD, ORAL; 1 DF, BID, ORAL; 1 DF,TID, ORAL; 200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (NGX)(METFORMIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD, ORAL; 1 DF, BID, ORAL; 1 DF,TID, ORAL; 200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (NGX)(METFORMIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD, ORAL; 1 DF, BID, ORAL; 1 DF,TID, ORAL; 200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (NGX)(METFORMIN) TABLET</medicinalproduct>
        <drugauthorizationnumb>75985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD, ORAL; 1 DF, BID, ORAL; 1 DF,TID, ORAL; 200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25533</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTEROSALPINGO-OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25391</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>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26240</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>820</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW20696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80 / 4.5 UG, 2 INHALATIONS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2-3 PUFFS EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>250 / 50</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001100</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>M60724AA</drugbatchnumb>
        <drugauthorizationnumb>74680</drugauthorizationnumb>
        <drugdosagetext>294 MG; 1X, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FALLOPIAN TUBE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>M60502AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>M61212AA</drugbatchnumb>
        <drugdosagetext>500 MG; IV-INF; IV; 1X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>M61212AA</drugbatchnumb>
        <drugdosagetext>500 MG; IV-INF; IV; 1X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>M61212AA</drugbatchnumb>
        <drugdosagetext>500 MG; IV-INF; IV; 1X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>M61212AA</drugbatchnumb>
        <drugdosagetext>500 MG; IV-INF; IV; 1X</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163144ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74656</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163311ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D),  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163117ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>75719</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423237-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-WYE-G00543307</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFEME</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>19190</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE388827SEP07</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>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>625UG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>125UG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163145ISR</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LINEAR IGA DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>61926</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0678</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09246</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugbatchnumb>N44484</drugbatchnumb>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>50 MG,</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGER (ZINGIBER OFFICINALE RHIZOME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG (GINSENG, GINSENG NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALMS (ASAFETIDA, FERULA ASSAFOETIDA, GENTIAN, GENTIANA LUTEA ROOT, HU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09240</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006JP14106</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4/CD8 RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD8 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>80339</drugauthorizationnumb>
        <drugdosagetext>ORAL; 75 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/D, ORAL; 22.5 MG/D, ORAL; 25 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG/D, ORAL; 22.5 MG/D, ORAL; 25 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENOSINE (GANCICLOVIR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006651</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGNET-RING CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIODIASTASE</medicinalproduct>
        <drugdosagetext>3 CASPSULES DAILY</drugdosagetext>
        <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>ENTERONON-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYFUL</medicinalproduct>
        <drugdosagetext>3G/3.6G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RACOL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027761</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>RENAL AND LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21872</drugauthorizationnumb>
        <drugdosagetext>IV; 1500 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8020541</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>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21872</drugauthorizationnumb>
        <drugdosagetext>1500 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027844</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDRODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D (3)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8016180</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>3000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1800 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>2400 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D (3)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027713</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004597</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>77345</drugauthorizationnumb>
        <drugdosagetext>50 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004632</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugauthorizationnumb>40188</drugauthorizationnumb>
        <drugdosagetext>X1; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002042</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200713018JP</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200712734DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugdosagetext>DOSE: NOT REPORTED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AVENTIS-200715063EU</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>INTRA-ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200710422US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 200 MCG/MIN WITHIN 24 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 200 MCG/MIN WITHIN 24 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINNTRATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-01807</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.10 MG, INTRAVENOUS; 1.62 MG, INTRAVENOUS; 1.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.10 MG, INTRAVENOUS; 1.62 MG, INTRAVENOUS; 1.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.10 MG, INTRAVENOUS; 1.62 MG, INTRAVENOUS; 1.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE (CALCIUM POLYSTYRRENE SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN (STREPTOCOCCUS FAECALIS, LACTOBACILLUS ACIDOPHILUS, BACILLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN (PANTETHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN CAPSULE (PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BENFOTIAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANNALBIN (ALBUMIN TANNATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN (PROCHLORPERAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPO (EPOETIN ALFA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION (FLURBIPROFEN AXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOL (DEXPANTHENOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMANT ANTI-D IMMUNGLOBULIN ^SSI^ (IMMUNOGLOBULIN HUMAN ANTI-RH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE (POVIDONE-IODINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEM, CILASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULENE (AZULENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARIVID OPHTHALMIC (OFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA A (VIDARABINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOSEGON (PENTAZOCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX-P (HYDROXYZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN-I</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID (SODIUM ALGINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX (HHYDROXYZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGYL (CLEMASTINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03525</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712810JP</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>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE                           /00228501/</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20071007876</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>OSTEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070805475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CY-AVENTIS-200720138GDDC</companynumb>
    <primarysource>
      <reportercountry>CYPRUS</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03595</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>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN (BETAMIRON, PANIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYRTIL (GRANISETRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03614</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>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03659</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200703222</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070501282</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTIN</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20071100572</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>5511123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20071100584</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>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511124-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711437</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706011</companynumb>
    <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021774</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>44 MCG X 3/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>11287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00481</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>41</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADRENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SILICOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE (HALOPERIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACIN (ISEPAMICIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEC-UP (NARTOGRASTIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K (ASPARTATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE (POTASSIUM CANRENOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCANIN (PROCAINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABEKACIN (ARBEKACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICOL (CALCIUM GLUCONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN (INSULIN HUMAN, INSULIN ISOPHANE, HUMAN BIOSYNTHETIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE (HALOPERIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYTWO (MENATETRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM FOR INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (IMIPENEM, CILASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AVENTIS-200720075GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-01685</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>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE (CALCIUM POLYSTYRENE SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART (NICORANDIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03194</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>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.20 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL (MACROGOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE) LIQUID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN (BETAMIPRON, PANIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04798</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04783</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004527</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77033</drugauthorizationnumb>
        <drugdosagetext>20 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISPAGHULA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09261</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75939</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV (AMOXICILLIN, CLAVULANATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-256392</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN NORDIFLEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DWARFISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060822</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-268998</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>.4 MG, QD</drugdosagetext>
        <drugindication>SMALL FOR DATES BABY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-268987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020908</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-263781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN NORDIFLEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>3.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE                         /00044702/</medicinalproduct>
        <drugindication>CUSHING'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H00973307</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>1 DOSE FORM/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL - SLOW RELEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESANBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRSTCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL ELIXIR</medicinalproduct>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061007</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRACIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-WYE-H00963107</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG (FREQUENCY UNSPECIFIED)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>^0,075 G^ (FREQUENCY UNSPECIFIED)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1500 MG (FREQUENCY UNSPECIFIED)</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-269123</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
        <drugdosagetext>90 UG/KG TOTAL: 4.8 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-258436</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 CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20907</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625 MG, UNK</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625 MG / 2.5MG, UNK</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625 MG /2.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625 MG/ 0.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625 MG/.05 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MPA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E                          /00110501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09243</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>18740</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NNOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002044</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>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002041</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002045</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02995</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugbatchnumb>167420</drugbatchnumb>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>100MCG/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OVARIAN FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACRIVASTINE</medicinalproduct>
        <drugdosagetext>24MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP11832</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ORGAN TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16282</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>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>69120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>69120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>69120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25765</companynumb>
    <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 OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25677</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UNDER 75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02928</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717810US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AVENTIS-200720252GDDC</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD KETONE BODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40N637</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717814US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720216GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004600</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76033</drugauthorizationnumb>
        <drugdosagetext>200 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN-S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004603</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>75960</drugauthorizationnumb>
        <drugdosagetext>100 MG; QID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004599</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>77345</drugauthorizationnumb>
        <drugdosagetext>125 MG; QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717332US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARAC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20985</drugauthorizationnumb>
        <drugdosagetext>DOSE: 0.5%</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KURIC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID CREAM NOS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAM                              /00012501/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 250</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710810BYL</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200711020BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.328</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL PALMAR/PLANTAR CREASES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710756BYL</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>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAKKON-TO</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 3.0 MG  UNIT DOSE: 1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 300 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN OD</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 5 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1.0 MG  UNIT DOSE: 0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUNCHO-TO</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.5 G  UNIT DOSE: 2.5 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 45 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 45 MG  UNIT DOSE: 15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1500 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL002573</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugauthorizationnumb>70468</drugauthorizationnumb>
        <drugdosagetext>120 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02036</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>105.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>59</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>20020319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>59</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>20020319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511170-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW15422</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25893</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</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>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511172-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25855</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710006853</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200708003009</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugauthorizationnumb>050521</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ELI_LILLY_AND_COMPANY-IE200707004269</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugdosagetext>UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>2.5 ML, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711000349</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</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>20071005</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-ELI_LILLY_AND_COMPANY-SA200710006948</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200710007477</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUGS FOR TREATMENT OF BONE DISEASES</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200711000375</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>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>A384196</drugbatchnumb>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ELI_LILLY_AND_COMPANY-PE200711001078</companynumb>
    <primarysource>
      <reportercountry>PERU</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A327070</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>A383448</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>900 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCLONAL ANTIBODIES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>32 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.336</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>A351070</drugbatchnumb>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>50 UG, OTHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>30 MG, 2/D</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN /01319601/</medicinalproduct>
        <drugdosagetext>160 MG, DAILY (1/D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>240 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>240 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>600 MG, 2/D</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>PANCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000063</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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE200710006923</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL 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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710007667</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOTICS AND SEDATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200711001094</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIO</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ELI_LILLY_AND_COMPANY-CN200710004708</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>750MG/M2 ON DAYS 1 AND 4 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>750 MG/M2, D1-D4 ,Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>12.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709006373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugindication>BILIARY CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000MG/M2, OTHER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>BILIARY CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708005368</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFERTILITY MALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710007603</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</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>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ELI_LILLY_AND_COMPANY-IE200705005984</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1250 MG/M2, ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>80 MG/M2 ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
        <drugdosagetext>175 U/KG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-LLY01-US200708002319</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>68.027</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, UNK</drugdosagetext>
        <drugindication>SMALL INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL200710003099</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>A266242</drugbatchnumb>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL /00975301/</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
        <drugdosagetext>3 X 3/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>8 I.E., DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>24 I.E., DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710007509</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>PENILE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200710007243</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>16 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIABET</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVAHEXAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3/W</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RADICAL PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>HORMONE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710007146</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>0.4 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAMYLENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-PRED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOTELON                          /00811401/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-264542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>56 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100289</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100360</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070905628</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANNICULITIS LOBULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITREPRESS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070104136</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 3 INFUSIONS ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 3 INFUSIONS ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 3 INFUSIONS ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 3 INFUSIONS ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMOVAL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0704976US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-BAXTER-2007BH008763</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIGNOCAINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROFOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG/KG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>125 MG/M2, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100241</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>COLORECTAL CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB*</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCLERITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070600074</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>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <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>
        <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>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-250890</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PURDUE-GBR_2007_0003391</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100249</companynumb>
    <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 NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511215-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100381</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100383</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FOURTH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THREE INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20061002178</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N36355, N01527, N02513, N42449,</drugbatchnumb>
        <drugdosagetext>1100 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
        <drugdosagetext>2 TABLET, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugdosagetext>3 TABLET, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAITAKE D-FRACTION</medicinalproduct>
        <drugdosagetext>15 G, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15535</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>4380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713590BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHILLIPS LIQUID GELS</medicinalproduct>
        <drugbatchnumb>249507F</drugbatchnumb>
        <drugdosagetext>UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20061203296</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <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>3.0 MG/KG, INITIATED ON 01-SEP-2005, FOLLOWED BY 4 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</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>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL MUCOSAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugdosagetext>3 CAPS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASURFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP07002283</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</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>AMNESTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1 ONLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE084010SEP07</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE445127JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE946010OCT05</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>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE728210APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE445627JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP07002257</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURADANTIN</medicinalproduct>
        <drugauthorizationnumb>16620</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAONIL(GLIBENCLAMIDE)</medicinalproduct>
        <drugdosagetext>5 MG, 3 DAY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM /01479302/(ESOMPERAZOLE MAGNESIUM)</medicinalproduct>
        <drugdosagetext>20 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIATEC /00116401/(PARACETAMOL, CODEINE PHOSPHATE)</medicinalproduct>
        <drugdosagetext>7.5 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD (INSULIN INJECTION, ISOPHANE) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP000639</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>44.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM (BENZBROMARONE) TABLET, 50 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN (VERAPAMIL HYDROCHLORIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION (NICERGOLINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAMAG G (MAGNESIUM OXIDE) POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13941398</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>CETUXIMAB 2MG/ML. THERAPY ONGOING. FIRST INFUSION ON 23JUL2007; DOSAGE OF 400MG/M2 1 IN 1 WEEK.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = AUC 5.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>MOST RECENT INFUSION ON 05/OCT/2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13932892</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13965629</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>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13971536</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>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13905567</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>13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugdosagetext>5TH COURSE END DATE:28AUG07,6TH COURSE STARTED DATE:29AUG07; 65 MG/M2,PO, BID(EXCEPT D1,CYCLE1, QD)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-529056</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRACIAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-528571</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY NOT PROVIDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugdosagetext>FREQUENCY NOT REPORTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPANIDIN</medicinalproduct>
        <drugdosagetext>FREQUENCY NOT REPORTED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-529584</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIFAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS UNSPECIFIED DRUG.</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS: VITA SENIOR (VITAMINS, MINERALS, GINSENG).</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-528828</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <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>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE DRUG NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-447831</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50758</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060416</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-484621</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>INTRA-ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50758</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-491531</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</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>LIVE BIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS DAILY.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGYNON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-528373</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511245-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-529621</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-528381</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-BAXTER-2007BH008764</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>7264A241</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMOCONIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-524401</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-529794</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS METHENAMINE ANHYDROMETHYLATE CITRATE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-354373</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>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>150 + 125</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugdosagetext>125+100</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>ADJUSTED TO REACH PREDEFINED LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>REDUCED TO 3 GRAM DAILY ON 19 DECEMBER 2003.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIUM BICARBONAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAHEXAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECOSTRIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-478347</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-528761</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS : 30MG FROM BOTTLE A AND 30MG FROM BOTTLE B. THE LAST DOSE WAS ADMINISTERED 16/10/+</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AVIAN INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS: GUAIACOLATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS: PARACETAMOL SYRUP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689691A</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7D30</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693084A</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>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693200A</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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693218A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693284A</companynumb>
    <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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693581A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0399794A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>16G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>560MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>280MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494522A</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>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494618A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugdosagetext>500MG EIGHT TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071007772</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>53.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071008039</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</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>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071008098</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100157</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>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071100180</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6 INFUSIONS RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100505</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071100562</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>70075014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>50,000 UNITS</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/10</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, /D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST (CARVEDILOL) PER ORAL NOS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FUROSEMIDE) PER ORAL NOS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE PER ORAL NOS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE (ENALAPRIL MALEATE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCARON (AMIODARONE HYDROCHLORIDE) PER ORAL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL PER ORAL NOS</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.1 %, TOPICAL ; 0.1 %</drugdosagetext>
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        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991210</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE) PER ORAL NOS</medicinalproduct>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPSYM (FLUOCINONIDE) OINTMENT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUATIM (NADIFLOXACIN) OINTMENT</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID EXTERNAL</medicinalproduct>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
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    <safetyreportid>5511275-X</safetyreportid>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020571</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTENAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE097309AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-WYE-H00965307</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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM OF AMPULLA OF VATER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 TO 400 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE835027AUG07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugbatchnumb>2005P1411</drugbatchnumb>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugbatchnumb>2005P1411</drugbatchnumb>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugdosagetext>3 ML Q4H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETHIONATE</medicinalproduct>
        <drugdosagetext>8.5 GM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00973107</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659712A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659718A</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>APPLICATION SITE ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROGEN PEROXIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BANDAGE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663703A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664316A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C269635</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664345A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C269635</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664827A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>CT96073</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665799A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666090A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666147A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666521A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666611A</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>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666905A</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>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667667A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667681A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667893A</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>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>270433</drugbatchnumb>
        <drugauthorizationnumb>22055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND DRAINAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667899A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugauthorizationnumb>050746</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667906A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667926A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668688A</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>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296078</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LACERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668704A</companynumb>
    <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 ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668708A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668710A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669218A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669219A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669508A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296081</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669827A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>G296079</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670177A</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>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670666A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BREAST ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670760A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671175A</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>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DIABETIC FOOT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671193A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671195A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673436A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C270433,C269635</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673440A</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296079</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673466A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674704A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHRITIS MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674768A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676054A</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>52.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676079A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676460A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676472A</companynumb>
    <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>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BLISTER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676972A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676973A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676974A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C270435</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676983A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROSS SENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677053A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677061A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C270435</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677095A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1PCT SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677417A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677739A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677768A</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>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677772A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>10MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677796A</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>APPLICATION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678126A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C270435</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678194A</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>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678205A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678412A</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>28.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CIRCUMCISION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678441A</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>SAMPLE</drugbatchnumb>
        <drugauthorizationnumb>22055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BLISTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678530A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678542A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678544A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678853A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WART EXCISION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678974A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN COSMETIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679212A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679269A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679681A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296073</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA/HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680279A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680280A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680908A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681448A</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>APPLICATION SITE PAPULES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C295074</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681635A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681665A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681905A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682109A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296072</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682110A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296072</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682111A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C296072</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682123A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682703A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683061A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683355A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>INFECTED INSECT BITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683376A</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683840A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C27</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684346A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684348A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684349A</companynumb>
    <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>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511371-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684353A</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>92.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>SAMPLE</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN LESION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684362A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684379A</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>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FACE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684435A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684691A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684707A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684710A</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>
      <patientweight>18.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684784A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684792A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685327A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685328A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685341A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>WOUND</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685343A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685348A</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>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685660A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685696A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686143A</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>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686144A</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>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686332A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1APP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686687A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686712A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686736A</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CYST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
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    <companynumb>A0686987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687160A</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>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>C269635</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE + EUCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687188A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687189A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-512674</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOGT-KOYANAGI-HARADA SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-512677</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOGT-KOYANAGI-HARADA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HN-ROCHE-518572</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>180</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-492406</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-512676</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOGT-KOYANAGI-HARADA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-528161</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPODONTIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>THE DOSE OF RIBAVIRIN WAS DECREASED IN MARCH 2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-525920</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>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-527024</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-527903</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-450692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <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>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN 1/35-21</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-509530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</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>19980313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-493711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 60 MG/40 MG AM/PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugindication>ALOPECIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-429952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>PRESCRIPTION - 40MG AND 20MG - T0TAL 60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-494047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>REPORTED ON THESE DATES AS GIVEN FOR CYSTIC ACNE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESONIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISTATIN</medicinalproduct>
        <drugdosagetext>REPORTED AS: TRIAMCIN WITH DOSING REGIMEN REPORTED AS: .1%/EUCERN 1:1.</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-525419</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>90.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>REPORTED AS MVI WITH CALCIUM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
        <drugdosagetext>REPORTED AS CALCIUM 600 MG + D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-520625</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>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugbatchnumb>MH6931101</drugbatchnumb>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-486491</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>TAKEN WITH MEALS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>.81</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI VIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGESTIVE ENZYMES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529225</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP010118</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>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-BID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RUEFRIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01743_2007</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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101858</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002932</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>
      <patientweight>3.99</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>0.2 TO 0.3 ML ONCE OR TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>0.2 TO 0.3 ML EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>0.2 TO 0.3 ML ONCE OR TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>0.2 TO 0.3 ML EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528336</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070603668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6KD4016</drugbatchnumb>
        <drugdosagetext>THE DOSE WAS INCREASED AND THE INFUSION FREQUENCY DECREASED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6KD4016</drugbatchnumb>
        <drugdosagetext>THE DOSE WAS INCREASED AND THE INFUSION FREQUENCY DECREASED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6KD4016</drugbatchnumb>
        <drugdosagetext>THE DOSE WAS INCREASED AND THE INFUSION FREQUENCY DECREASED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6KD4016</drugbatchnumb>
        <drugdosagetext>THE DOSE WAS INCREASED AND THE INFUSION FREQUENCY DECREASED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-JNJFOC-20071100593</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071004335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROCIN LACTOBIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JUZEN-TAIHO-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006140</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>22106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071006130</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071100934</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>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERSIGAN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE GARGLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070805674</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0633870</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0633870</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINE ABNORMALITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708404</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>2X 75UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIACTIV</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CALCIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>HALF A 25MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>AT 4 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0629776</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0629776</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100906</companynumb>
    <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0702240</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugauthorizationnumb>020628</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugauthorizationnumb>020628</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-500011</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</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>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-521766</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>67.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-528927</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOESOPHAGEAL DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10691</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC MYCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>40 MG/M2 QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>18 MG/KG QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSEODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17721</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugauthorizationnumb>71484</drugauthorizationnumb>
        <drugdosagetext>1.9 MG Q21DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1 MG FREQ IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1450 MG Q21DAYS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-461267</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 THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 180 MCG/0.5 ML.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>SWITCHED FROM COPEGUS TO RIBAVIRIN (UNKNOWN MANUFACTURER)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>SWITCHED FROM COPEGUS TO RIBAVIRIN (UNKNOWN MANUFACTURER)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>AT BEDTIME.</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TAKES 40 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071101434</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071102497</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIORIDAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZATROPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071102524</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>1092</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071102548</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071102582</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL DECANOAS</medicinalproduct>
        <drugauthorizationnumb>18701</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071100888</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FOOD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORFENAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>20603</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>020603</drugauthorizationnumb>
        <drugindication>TEETHING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-410535</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>94.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>C210884-06</drugbatchnumb>
        <drugdosagetext>FORM STATED AS LIQUID.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>C208293009</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>TUES/THURS/SAT.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANDELION</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>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-516853</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</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>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN (NON-ROCHE)</medicinalproduct>
        <drugdosagetext>PATIENT REPORTED TO BE ON GENERIC REBETOL, RIBASPHERE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17738</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>25 MG FREQ IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG FREQ IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG WEEKLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMELLOSE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL /00016701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISPAGHULA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCILON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVINYL ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17733</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>22.5 MG FREQ</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG FREQ SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061224</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17714</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAUCHER'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugauthorizationnumb>71484</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>200 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-KINGPHARMUSA00001-K200700918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugauthorizationnumb>020859</drugauthorizationnumb>
        <drugdosagetext>420 MG, 42 CAPSULES, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070305294</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>ELECTROCARDIOGRAM QT INTERVAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071102736</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102500</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>48.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM ADVANCED</medicinalproduct>
        <drugbatchnumb>LCF086</drugbatchnumb>
        <drugauthorizationnumb>020606</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM ADVANCED</medicinalproduct>
        <drugbatchnumb>LCF086</drugbatchnumb>
        <drugauthorizationnumb>020606</drugauthorizationnumb>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100216</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>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>70M73013;07C042P1</drugbatchnumb>
        <drugdosagetext>WEEK 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>70M73013;07C042P1</drugbatchnumb>
        <drugdosagetext>WEEK 0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>70M73013;07C042P1</drugbatchnumb>
        <drugdosagetext>2 DOSES GIVEN IN 2001</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG OX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100582</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>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070800991</companynumb>
    <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070800496</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>07B103P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>07B103P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>07B103P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>07B103P1</drugbatchnumb>
        <drugdosagetext>3 INFUSIONS ON UNSPECIFIED DATES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</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>TRIAZOLAM</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1-2 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW14860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>134.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANDROGEN DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06770</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>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPARTUM CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTOCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOMETRINE MALEATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06515</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>
      <patientonsetage>12215</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE SOLUTION 4%</medicinalproduct>
        <drugauthorizationnumb>010417</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
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        <drugstartdate>20050122</drugstartdate>
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        <drugenddate>20050122</drugenddate>
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  <safetyreport>
    <safetyreportid>5511474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>DE-ASTRAZENECA-2007PK02305</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>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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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>
      <patientonsetage>26328</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</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>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06514</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCAINE AMPOULE</medicinalproduct>
        <drugauthorizationnumb>89406</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01570</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16474</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELOCURINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511478-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200710007487</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>22 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0670772A</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>88.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0677021A</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>109.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0686175A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>20G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689546A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>R306082</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>5TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691429A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691446A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>0296079</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>IMPETIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691448A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691454A</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 POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691541A</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>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691716A</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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691717A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTABAX</medicinalproduct>
        <drugbatchnumb>0007518022,0007518022</drugbatchnumb>
        <drugauthorizationnumb>022055</drugauthorizationnumb>
        <drugdosagetext>1PCT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691732A</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>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691745A</companynumb>
    <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>TYKERB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693051A</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693068A</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693076A</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TRIAL MEDICATION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693628A</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693642A</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693645A</companynumb>
    <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>LUNG DISORDER</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>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693647A</companynumb>
    <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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693649A</companynumb>
    <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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693650A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693661A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0446140A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0480927A</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>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488831A</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</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>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489044A</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>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBIN LOCAL SOLUTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492877A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>AMIMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492932A</companynumb>
    <primarysource>
      <reportercountry>UGANDA</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493414A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THEFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493530A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugdosagetext>6TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493543A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>400MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493724A</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>16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>70MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugauthorizationnumb>009386</drugauthorizationnumb>
        <drugdosagetext>1.1MGK FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEITEN</medicinalproduct>
        <drugdosagetext>1.8G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMYLAL SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSMIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUART</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYTWO N</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA CYTOMEGALOVIRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>15ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugdosagetext>45MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493847A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugdosagetext>8MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>40MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCLONAL ANTIBODY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugdosagetext>2TAB AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOYL</medicinalproduct>
        <drugdosagetext>2SP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494063A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L THYROXINE</medicinalproduct>
        <drugdosagetext>23DROP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494120A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494123A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugauthorizationnumb>021548</drugauthorizationnumb>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494154A</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCOAGULABLE STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETENSIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494212A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENAL</medicinalproduct>
        <drugdosagetext>100MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>710</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>770</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
        <drugdosagetext>625MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRACTAZIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>770</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494225A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN GRAFT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN V</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494229A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMCOLIT</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>320MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494233A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>320MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>18MCG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494387A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>38MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>190MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494407A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADARTREL</medicinalproduct>
        <drugauthorizationnumb>20658</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494512A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494524A</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>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID OVERLOAD</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLAZONE</medicinalproduct>
        <drugdosagetext>800MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494534A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>100MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494539A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494553A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIVEXA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEBUTID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494567A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494573A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXOMUC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL LP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054162A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugdosagetext>800MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054980A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugauthorizationnumb>020711</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20070905434</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>GRAND MAL CONVULSION</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>5511534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071102381</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 24HR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 24HR</medicinalproduct>
        <drugauthorizationnumb>020021</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100973</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102405</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>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071005383</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE075406AUG04</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 RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00615</companynumb>
    <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>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06120</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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SWELLING</reactionmeddrapt>
      </reaction>
      <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>20000218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0509USA04012</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>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00543</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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711USA01257</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>146</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA00871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
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        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
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  <safetyreport>
    <safetyreportid>5511548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
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  <safetyreport>
    <safetyreportid>5511549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <primarysource>
      <reportercountry>CHINA</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>20505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20070904055</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20070301236</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YONDELIS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YONDELIS</medicinalproduct>
        <drugauthorizationnumb>050286</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </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>ODANSETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511556-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071006634</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20050903231</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPROXAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20051003438</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>4 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugdosagetext>3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SUL INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SUL INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>ONE AND A HALF</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TENIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TENIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugdosagetext>32.5 MG + 325MG TAKE 1 OR 2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20070502371</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <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>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-250888</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, 1/WEEK</drugdosagetext>
        <drugindication>CRYOGLOBULINAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0423553-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCRELIPASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423036-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE DE SODIUM WINTHROP LP TABLET PR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE DE SODIUM WINTHROP LP TABLET PR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20071004999</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
        <drugauthorizationnumb>016921</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE102514JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000125</drugenddate>
        <drugtreatmentduration>1619</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE015802FEB05</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>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE270120JUL04</companynumb>
    <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>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00964207</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE087526OCT04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18416</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>160MG VAL/12.5MG HCT, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-07P-229-0423244-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18214</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>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14335</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03259</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>336MG PER 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705830</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>113.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 TO 4 EACH NIGHT AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200701437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG/M2 GIVEN AS BOLUS FOLLOWED BY 2400 MG/M2 CONTINUOUSLY OVER 46 HOURS EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ABBOTT-07P-009-0423038-00</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GENENTECH-250789</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712536</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200708968</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>600 MG IV BOLUS FOLLOWED BY 3750MG CONTINUOUS INFUSION ON D1+2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070202</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008510</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>07G23BM</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP07061</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>FOR MANY YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE05950</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29781</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET TABLETS 2.5MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-ASTRAZENECA-2007SE05829</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050820</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ASTRAZENECA-2007PK00800</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>532</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRAT RET 400</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG00886</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ASTRAZENECA-2007AC02144</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ASTRAZENECA-2007SE05938</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</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>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008813</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>CALCIUM IONISED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MATERNAL THERAPY TO ENHANCE FOETAL LUNG MATURITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-WYE-H00966007</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIKET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-WYE-G00550207</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATISATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFADAR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>UNKOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-H00966207</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG EVERY 1 TOT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>DUODENITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANZYTRAT</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>^DF^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511596-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008512</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>07G23BM</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423199-00</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>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50739</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BAXTER-2007BH008772</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>204170407</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>204170407</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250732</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, D1,15,29</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200710496</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDITRANS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON OD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200710316</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>797</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEW LECICARBON</medicinalproduct>
        <drugdosagetext>1-2 DOSE FORM PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029028</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>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STERNAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISCERAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-529303</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE IV</medicinalproduct>
        <drugauthorizationnumb>19661</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CONGENITAL CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE IV</medicinalproduct>
        <drugauthorizationnumb>019661</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061212</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014117</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>RECTAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13840756</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-480551</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200610001471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
        <drugtreatmentduration>612</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061002</drugenddate>
        <drugtreatmentduration>477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>6 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>4 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
        <drugtreatmentduration>321</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060123</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
        <drugtreatmentduration>321</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION                                 /NET/</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1.5 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>1.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050711</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>1 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000967</companynumb>
    <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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 UNK, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY ESSENTIAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710007118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200708006579</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>880 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>130 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070317</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</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>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-269183</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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
        <drugdosagetext>90 UG / KG TOTAL: 4.8 MG</drugdosagetext>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-05P-167-0285498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00566707</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugindication>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>22.5 MG TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>250 MG TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>0.40 ML TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 DOSE TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>1 DOSE TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>80 MG TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>200 MG TOTAL DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-H00965207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugdosagetext>1 DF OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00488807</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR IX INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugbatchnumb>LE07F046AA/LE07F046AA</drugbatchnumb>
        <drugdosagetext>500 IU EVERY 1 TOT</drugdosagetext>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00488807</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR IX INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugbatchnumb>LE07F046AA/LE07F046AA</drugbatchnumb>
        <drugdosagetext>500 IU EVERY 1 TOT</drugdosagetext>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-250725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092081</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUTIONS FOR PARENTERAL NUTRITION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.545</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007091374</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>TEXT:60 TO 80 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT12475</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>30 MG/KG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007043262</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007061186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:37.5MG-FREQ:EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1MG-FREQ:3 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1MG-FREQ:3 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:5MG-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007047709</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2003167160US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:300MG-FREQ:CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:500MG/M2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE W/DIPHENOXYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-001-0184-M0000026</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:225MG-FREQ:UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2005083835</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLINTER HAEMORRHAGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006007527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006017991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugbatchnumb>58333A51</drugbatchnumb>
        <drugauthorizationnumb>021212</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
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      <drug>
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        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2006057955</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>506679</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
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        <drugenddate>20060427</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYDROGEN CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
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        <drugenddate>20060301</drugenddate>
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  <safetyreport>
    <safetyreportid>5511636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>US-PFIZER INC-2003160616US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030521</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030509</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030509</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030511</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030509</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>US-PFIZER INC-2007011091</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugauthorizationnumb>017783</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5511638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007085122</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>CATARACT</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007087752</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
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        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
        <drugauthorizationnumb>19661</drugauthorizationnumb>
        <drugdosagetext>GIVEN AS INFUSION.</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
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        <medicinalproduct>LYRICA</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511641-2</safetyreportid>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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        <medicinalproduct>ALBUTEROL</medicinalproduct>
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    <safetyreportid>5511642-4</safetyreportid>
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      <reportercountry>JAPAN</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <reportercountry>CZECH REPUBLIC</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNODEFICIENCY COMMON VARIABLE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007086933</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugindication>HYPERALDOSTERONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712242</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>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11089</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPERSIBLE ASPIRIN 75MG TABLETS BP</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 50MG</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-07991</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>5 ML, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11093</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN 4MG TABLETS</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11049</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONGENITAL MUSCULOSKELETAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75556</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 100MG</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423404-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICARE D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11103</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-RANBAXY-2007RR-11115</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOLO RANBAXY 120MG/5ML SOLUZIONE ORALE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-08986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11099</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN 500MG TABLETS</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060127</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL 10MG TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV 125/31 ORAL SUSPENSION SUGAR-FREE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE 10MG TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2007RR-11183</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOX 100MG BASICS</medicinalproduct>
        <drugauthorizationnumb>76220</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOX 100MG BASICS</medicinalproduct>
        <drugauthorizationnumb>076220</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11095</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN 500MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>21591</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN 500MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN 500MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN 500MG TABLETS</medicinalproduct>
        <drugauthorizationnumb>021591</drugauthorizationnumb>
        <drugdosagetext>2000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPERSIBLE ASPIRIN 75MG TABLETS BP</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>672</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL 5MG TABLETS</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN-S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL 2.5 MG CAPSULES</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11121</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE TABLETS BP 15MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007086727</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>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPEN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEW LECICARBON</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORRAGINOL-N</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-E2B_00000016</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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-07160</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM NORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugauthorizationnumb>78010</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006143725</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007061801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TABLETS</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007067029</companynumb>
    <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>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007060598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF THYROID GLAND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007056856</companynumb>
    <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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007043480</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>GENERAL PHYSICAL CONDITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GILEAD-2007-0013673</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713562BCC</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>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACOUSTIC NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMIC INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 81 MG  UNIT DOSE: 81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>THROMBOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 75 MG  UNIT DOSE: 75 MG</drugdosagetext>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200711338</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS STASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPICOT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713518BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 325 MG  UNIT DOSE: 325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANGRELOR VS. PLACEBO</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0354417-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PEN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-SANOFI-SYNTHELABO-A01200712230</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713545BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00590107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW26038</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>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ASTRAZENECA-2007SE05878</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOPTIC EYE DROPS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTELAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2007SE03643</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29019</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT HEPATOBILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIRENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW02060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA INFECTION</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>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06971</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01437</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23523</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01060</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13154</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIDROLASE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVEDOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW01899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25-600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-07P-217-0423153-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>.8 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </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>PREDNISONE</medicinalproduct>
        <drugdosagetext>5-10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UDRAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTIFAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>2-0-2</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOFLORA/LEPICOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250823</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DETACHMENT OF RETINAL PIGMENT EPITHELIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-202092</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020129</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>14 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>N53565</drugbatchnumb>
        <drugdosagetext>1 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOTOTHERAPY</medicinalproduct>
        <drugdosagetext>UNK, 3/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200711713BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REYE'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-GILEAD-2007-0014225</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423252-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERSONAL HYGIENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>PROGRESSIVE WEANING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511702-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511703-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250415</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>50018B</drugbatchnumb>
        <drugdosagetext>300 UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511704-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007051782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-GEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007047402</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE (MICRONIZED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511707-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007087242</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>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-07P-151-0422739-00</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>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0422736-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROPAKINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423354-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE236426JUL07</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAMBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HISTIOCYTOSIS HAEMATOPHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423033-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDODEMENTIA</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>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE644217AUG07</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PN TWIN</medicinalproduct>
        <drugdosagetext>1100 MG/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422851-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</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>20070416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250411</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091036</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>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:3600MG</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007076945</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200700541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</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>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTEGRILIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MCG/MIN CONTINOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200700452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG (2 CAPSULES) BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG (2 TABLETS) BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010328</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511720-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007074691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200704004</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRYPTASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL SEPTAL DEFECT REPAIR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-GENENTECH-249332</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PURPURA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVES NOS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007072323</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugbatchnumb>0541027</drugbatchnumb>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>TEXT:10MG/10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugbatchnumb>0541027</drugbatchnumb>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 FOR INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 FOR INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706251</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706267</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>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUBEROL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091385</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-249131</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.667</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091859</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>017892</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007070299</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugdosagetext>TEXT:10MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007071579</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007069591</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROSTATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPRORELIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEOPLASM PROSTATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM SULFOBENZOATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23948RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23950RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPRESSIVE LANGUAGE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076270</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-23951RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076270</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROXANE LABORATORIES, INC-2007-BP-24017RO</companynumb>
    <primarysource></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>CYTOMEGALOVIRUS GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD AVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARASITE STOOL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROXANE LABORATORIES, INC-2007-BP-24014RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>006134</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>REVERSAL OF OPIATE ACTIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24006RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILK-ALKALI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERCALCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N52713</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007075157</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>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-PFIZER INC-2007083908</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TABLETS</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-PFIZER INC-2007084494</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CICLONIUM BROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANTUM VERDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANTUM VERDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007083888</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOVITE</medicinalproduct>
        <drugdosagetext>FREQ:DAILY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERAZETTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082725</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>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007083791</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-245830</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>675 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>FREQ:EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS WITH MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPRAZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007081183</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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>FREQ:24MG/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-PFIZER INC-2007080357</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>53.968</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N38279</drugbatchnumb>
        <drugdosagetext>536 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>149 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5511759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007079517</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071031</receiptdate>
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    <companynumb>US-PFIZER INC-2007079034</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>BACTERAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
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  <safetyreport>
    <safetyreportid>5511761-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071026</receiptdate>
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    <companynumb>JP-GENENTECH-250840</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugbatchnumb>UNKNOWN</drugbatchnumb>
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        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HCL ELIXIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511762-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
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    <companynumb>ES-PFIZER INC-2007078935</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>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>020779</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5511764-8</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>JP-PFIZER INC-2007091841</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
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        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
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        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250838</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>990 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511767-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091848</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-250837</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007087392</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GILEAD-2007-0012988</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugauthorizationnumb>021500</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007086803</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250740</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/M2, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>85 MG/M2, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2400 MG/M2, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>400 MG/M2, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2007084141</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 AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007084637</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONIDASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007082667</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPORPHYRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19650101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250677</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>METASTASES TO SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089551</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007089049</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007088595</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.5UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROTOXICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:500MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:300MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FALLOPIAN TUBE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0422860-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-07P-122-0421355-00</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>VARIOUS DOSES</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250583</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>48.72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.3 MG/M2, Q3W</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007088138</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511788-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007088330</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2007086981</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORAXELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088086</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050784</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANLUKAST HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-PFIZER INC-2007091026</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091012</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090962</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007091004</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugauthorizationnumb>050674</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTINATE SEPTIMUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007090945</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:18MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>FREQ:DAILY</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23017BP</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>074190</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23853BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23854BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24085BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENF</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NRTIS</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23856BP</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24174YA</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24190BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22979BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT HFA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22963BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM TABLETS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20071001</drugstartdate>
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        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
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    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24225BP</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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        <drugstartdate>20040413</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23857BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
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    <safetyreportid>5511812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24151BP</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5511813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
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    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23098NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061030</drugstartdate>
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        <drugenddate>20061229</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071102</receiptdate>
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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>
      <patientonsetage>78</patientonsetage>
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      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LUNG CYST BENIGN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugbatchnumb>718639</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>REPORTED IN THE NARRATIVE</drugdosagetext>
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        <drugindication>BRONCHITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>718639</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
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    <safetyreportid>5511815-0</safetyreportid>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugstartdate>20030905</drugstartdate>
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    <safetyreportid>5511816-2</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>DRUG INEFFECTIVE</reactionmeddrapt>
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        <drugstartdate>20071010</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
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        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20030808</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>DILTAHEXAL</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENALAPRIL</medicinalproduct>
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      <drug>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEMINOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
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    <safetyreportid>5511818-6</safetyreportid>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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    <safetyreportid>5511819-8</safetyreportid>
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    <sender>
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    <receiver></receiver>
    <patient>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06584GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06586GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06638GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06639GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06648GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06597GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06596GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06592GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06591GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
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        <drugenddate>20050111</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
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        <drugenddate>20050125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUMIL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESOLON</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTERONE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20031205</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511830-7</safetyreportid>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugstartdate>20031029</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511831-9</safetyreportid>
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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>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06641GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYFERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIMOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06644GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23006BP</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</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>20050101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06640GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
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        <drugenddate>20031020</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06607GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
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  <safetyreport>
    <safetyreportid>5511837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06614GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
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        <drugenddate>20031027</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
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        <drugenddate>20031021</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06590GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMICEPHALALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VERTEBROBASILAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
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  <safetyreport>
    <safetyreportid>5511841-1</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>CONDITION AGGRAVATED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
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        <drugauthorizationnumb>020667</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5511842-3</safetyreportid>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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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>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
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        <drugstartdate>20050101</drugstartdate>
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    <safetyreportid>5511843-5</safetyreportid>
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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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
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        <drugauthorizationnumb>020667</drugauthorizationnumb>
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        <drugstartdate>20070720</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE NASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B COMPLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-MAG-CITRATE PLUS D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE GUARD PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06593GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06603GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06612GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06585GD</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06583GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORFIDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06581GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06579GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL RATIOPHARM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURO 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASS 100 HEXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06575GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL ARTERY OCCLUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20031103</drugstartdate>
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        <drugenddate>20040718</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAURIN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
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        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20031112</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREBON</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5511854-X</safetyreportid>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06523GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06548GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06531GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06510GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL TYPE ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0366200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>393439A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
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    <companynumb>CA-ABBOTT-07P-028-0423400-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021402</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511863-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <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>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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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>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423193-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50749</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0424011-00</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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0422746-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AIDS RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugdosagetext>400/100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0420808-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0418262-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2007090689</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090278</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2007090169</companynumb>
    <primarysource>
      <reportercountry>PERU</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091186</companynumb>
    <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 VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>020607</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091489</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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:3GRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091493</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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIKELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250785</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIABETIC DRUG NOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091462</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091469</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEUROPATHY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091434</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091443</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007091404</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPHOSPHONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247431</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</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>20050124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPHOBARBITAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091321</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091081</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:250MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:130MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091262</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007091107</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250851</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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG/M2, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PEMPHIGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091474</companynumb>
    <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPRODUCTIVE TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM EXTENDED-RELEASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091476</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM EXTENDED-RELEASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-250786</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>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>920 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>500 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091768</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>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423386-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020630</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020630</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE BROMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-07P-150-0415553-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 INJECTIONS IN TOTAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTELAC SOLUTION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-07P-229-0423216-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091743</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091747</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISTIN</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091741</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2.5MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPINYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:600MG-TEXT:600 MG TOTAL DAILY DOSE</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250448</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>85 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091736</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007091681</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>017892</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, 1/WEEK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG/KG, 1/WEEK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABI-007</medicinalproduct>
        <drugdosagetext>100 MG/M2, 1/WEEK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>767 MG, SINGLE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2007091700</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007091622</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091970</companynumb>
    <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091953</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE/S,S-REBOXETINE SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-251047</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>38 DF, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL ARTERY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOW MOLECULAR DEXTRAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091949</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007091893</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00401507</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMOPAX MONO</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007091896</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL W/BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423207-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20528</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020528</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALENIC /FLUTICASONE/SALMETEROL/</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN INCREASED</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>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423312-00</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>
      <patientweight>130</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.545</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>STEROID ANTIBACTERIALS</medicinalproduct>
        <drugindication>LUNG TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007091833</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARPAGOPHYTUM PROCUMBENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007091791</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>INFERTILITY MALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091812</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092056</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:0.5MG BID EVERY DAY TDD:1.0MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092031</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092412</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>118.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2007092418</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2007092398</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGININE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>16931</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:60GRAM</drugdosagetext>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007092338</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>TEXT:5/20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007092382</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0333266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHORDEE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <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>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINIVIR SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092301</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>FREQ:EVERY DAY</drugdosagetext>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DERMATITIS CONTACT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>LUNG TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092184</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>LUNG TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092166</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092171</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092439</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETRUSITOL XL</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092578</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092575</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>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IS-PFIZER INC-2007092563</companynumb>
    <primarysource>
      <reportercountry>ICELAND</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007092556</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092486</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092476</companynumb>
    <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 APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA01918</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
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        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <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>ALCOHOL ABUSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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        <drugstartdate>19971101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugenddate>20050101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>GB-MERCK-0711GBR00043</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA02570</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>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5511962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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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>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</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>ORAL DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</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>WRIST FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511963-5</safetyreportid>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>DE-MERCK-0709DEU00873</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
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        <drugindication>ASTHMA</drugindication>
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        <drugstartdate>19990505</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5511964-7</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>FRANCE</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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  <safetyreport>
    <safetyreportid>5511966-0</safetyreportid>
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      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <drugcharacterization>1</drugcharacterization>
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      <drug>
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    <companynumb>JP-MERCK-0710USA02284</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>SPINOCEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGIC BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0711FRA00002</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMANDOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00030</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0709USA01023</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</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>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030915</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA01514</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENINGIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIGLAUCOMA PREPARATIONS AND MIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007092472</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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TABLETS</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-233439</companynumb>
    <primarysource>
      <reportercountry>LEBANON</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT  REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, X2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092464</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>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIENE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 5MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00029</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0710FRA00054</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugauthorizationnumb>19384</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTINAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA02579</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00028</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>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711USA01845</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAREDISOL</medicinalproduct>
        <drugauthorizationnumb>080778</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PERNICIOUS ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00025</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00031</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>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0710BEL00021</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</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>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL AND NORETHINDRONE ACETATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA05857</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>271</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GROIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA04354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00646</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>137</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugbatchnumb>U2643</drugbatchnumb>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA03589</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0711CHN00005</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0710BEL00020</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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 FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTILYMPHOCYTE IMMUNOGLOBULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EVIDENCE BASED TREATMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA05557</companynumb>
    <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CITROBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA04993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00541</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>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00045</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAFIRLUKAST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00026</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0708USA01657</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugauthorizationnumb>018201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugauthorizationnumb>018201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0710ESP00043</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL POLYPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA02390</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>20869</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHAZOLAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5511999-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00787</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512000-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00983</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROGENITAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512001-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA02568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ATOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512002-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA05658</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512003-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA01631</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512004-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00027</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <receiptdate>20071031</receiptdate>
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    <companynumb>GB-PFIZER INC-2007092465</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-PFIZER INC-2007093128</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093004</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>020287</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0706ITA00041</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
        <drugtreatmentduration>2770</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND ASPIRIN AND MAGNESIUM HYDROXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-PFIZER INC-2007092992</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2007092982</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092948</companynumb>
    <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>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GILBERT'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENENTECH-250782</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>POEMS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>POEMS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>POEMS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250942</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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007092604</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093923</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093912</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>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093891</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>FREQ:1 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06541GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512023-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06515GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06514GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06511GD</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06517GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06558GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06498GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06501GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5512030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06539GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5512031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGIMERCK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06520GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06532GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23344BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23272BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06537GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGYNON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06519GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06516GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06503GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDUCTAL MR</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERTENSIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22985BP</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>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22984BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</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>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</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>5512042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22887BP</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</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>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>O2</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22868BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23992BP</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR AND RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512045-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23271BP</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>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704894A,7C3200</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24150BP</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>765068A</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22976BP</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>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>756379A</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512048-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06554GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBO ASS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIFON</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512049-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
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    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23235NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>46.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
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        <drugenddate>20070819</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
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        <drugenddate>20070819</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020606</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC (POLAPREZINC)</medicinalproduct>
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        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
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        <drugenddate>20070819</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINZAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERPAMINE (DENOPAMINE)</medicinalproduct>
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        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
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  <safetyreport>
    <safetyreportid>5512050-2</safetyreportid>
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    <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5512051-4</safetyreportid>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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  <safetyreport>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06553GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE-B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06555GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06561GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEISSERIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5512072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06563GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06566GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
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  <safetyreport>
    <safetyreportid>5512074-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06568GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5512075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06569GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512076-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06522GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20031117</drugstartdate>
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  <safetyreport>
    <safetyreportid>5512077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>COUGH</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
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  <safetyreport>
    <safetyreportid>5512078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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        <drugstartdate>20040128</drugstartdate>
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  <safetyreport>
    <safetyreportid>5512080-0</safetyreportid>
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    <sender>
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    <patient>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
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        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <drug>
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        <patientdeathdate></patientdeathdate>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECOTEX CAPSULES 0.4MG</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23929MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECOTEX CAPSULES 0.4MG</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23521BP</companynumb>
    <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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23993BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23916MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECOTEX CAPSULES 0.4MG</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093890</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>FREQ:1 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093646</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-250936</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093595</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093437</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>N53565</drugbatchnumb>
        <drugdosagetext>1 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL STEROID NOS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>TEXT:20MG</drugdosagetext>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007093236</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>TEXT:MANE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2007093232</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOPERAZONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093164</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>TEXT:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>TEXT:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>TEXT:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092958</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-2007091413</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PH-797,804</medicinalproduct>
        <drugauthorizationnumb>70902</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMONACIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093223</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KAWASAKI'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GENENTECH-246739</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B3124</drugbatchnumb>
        <drugdosagetext>800 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>317</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFENIDOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512128-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-248448</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250958</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>RITUXAN</medicinalproduct>
        <drugbatchnumb>N65720</drugbatchnumb>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>N40626</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512130-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02736</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>865</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW-D3 MITE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071111</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-0712289US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYSPORT</medicinalproduct>
        <drugdosagetext>700 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYSPORT</medicinalproduct>
        <drugdosagetext>1000 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071111</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0712281US</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>1400 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071111</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200611001700</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE</medicinalproduct>
        <drugdosagetext>250 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-007417</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>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3095A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 M, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URECHOLINE</medicinalproduct>
        <drugdosagetext>25 MG, 2, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG/D, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRATE</medicinalproduct>
        <drugdosagetext>600 D, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>.4 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>100 UNK, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650,2, AS REQ'D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>1 UNK, AS REQ'D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENULOSE</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-002297</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>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-030780</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>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A E D</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6 - B12</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042109</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-009431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>566</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-010024</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA0992A</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4890A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-009223</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>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>16 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-009194</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1615</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-009476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-015952</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>283</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SHR-IT-2007-027297</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>200 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SHR-KR-2007-041979</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>72321</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>150 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM THORAX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-042140</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>10 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-041972</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETIBELLE 30 (21)</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SHR-AU-2007-041423</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-030324</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>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-041681</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SHR-AU-2007-041051</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-022769</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>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050719</drugenddate>
        <drugtreatmentduration>2342</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
        <drugtreatmentduration>431</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041082</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>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE.</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041201</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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>MA9003A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-031320</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>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041013</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SHR-MX-2007-003260</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGELIQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021355</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE 600+B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-007020</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>4571</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3532A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-008079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDICATION FOR COUGH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-042357</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>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, 1X/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG/M2, 1X/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2005-008456</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050427</drugenddate>
        <drugtreatmentduration>864</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033986</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>SIGNET-RING CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GM-CSF (9874)</medicinalproduct>
        <drugdosagetext>6 A?G/KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GM-CSF (9874)</medicinalproduct>
        <drugdosagetext>6 A?G/KG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>5 G, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, AS REQ'D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500-1000MG</drugdosagetext>
        <drugindication>FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>PREMED PRIOR TO LEUKINE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
        <drugdosagetext>PREMED PRIOR TO LEUKINE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050322</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18346</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>3 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>60 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>5 UG/KG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007LB18412</companynumb>
    <primarysource>
      <reportercountry>LEBANON</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400MG /DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CL18434</companynumb>
    <primarysource>
      <reportercountry>CHILE</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>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG D</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>VALS 160 / HCT 12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007EC18433</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROSIN</medicinalproduct>
        <drugdosagetext>300MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512168-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN17916</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugauthorizationnumb>020261</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18404</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES18445</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION TRACHEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEPROTON</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARATOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREMIS</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NO18367</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, QW</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03477</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600MG EVERY 72 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>54720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATITIS B IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18423</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <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>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18466</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>60 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T1 INJECTION</medicinalproduct>
        <drugdosagetext>1000 ML/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugdosagetext>1.2 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WAKOBITAL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007NZ18258</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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14498</companynumb>
    <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 TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG M-W-F</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS AND IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN /UNK/</medicinalproduct>
        <drugdosagetext>ON SUNDAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN W/GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050726</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>3.5 MG MONTHLY</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>787</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5/325 MG Q6H PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugdosagetext>150 MG QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007HK18653</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</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>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>42 G, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>102.5 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>2.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14421</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>Q2WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14494</companynumb>
    <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>GASTRIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18429</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 400MG TABLETS, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512182-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14496</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BR18600</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALVUS MET</medicinalproduct>
        <drugdosagetext>10/500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007KR18421</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS ECHOCARDIOGRAM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugauthorizationnumb>020144</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>80/150</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US18442</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>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY OSTIAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18497</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512189-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18299</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14276</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>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512191-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP06659</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES18425</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PROMYELOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2006TW18238</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061028</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIABETICS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP18120</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007FI18462</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>135 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>175 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>3 TAB/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061212</drugenddate>
        <drugtreatmentduration>90720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IE18508</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CA18613</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAPAROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>GRADUALLY INCREASED TO 600 MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HYDROPHILIC MUCILLOID</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DK18573</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACE INHIBITORS AND DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA01909</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>19</drugbatchnumb>
        <drugdosagetext>7.5MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12278</companynumb>
    <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>011793</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US15872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001 VS PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001 VS PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TW03675</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE02396</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>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBIOTIC PROPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>72000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
        <drugtreatmentduration>63360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>25 UG/H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>10.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENASE</medicinalproduct>
        <drugdosagetext>2 UG/DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CN18177</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007GT18432</companynumb>
    <primarysource>
      <reportercountry>GUATEMALA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED VENTRICULAR AFTERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18490</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>482</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES17922</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIORIDAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, DISORGANISED TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</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>ACTOS</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>1 DRP, BID, OD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 DRP, QD, OD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
        <drugdosagetext>1 DRP, BID, OS</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17345</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO MORE THAN A YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007MX18200</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</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>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>66240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512216-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18354</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPLICTIL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DZ18112</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFLOQUINE</medicinalproduct>
        <drugdosagetext>1 TABLET ONCE A WEEK FOR 5 ONE PILL PER WEEK</drugdosagetext>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IL17633</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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDACTEROL VS FORMOTEROL VS PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>12 UG, BID</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2565</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17703</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP PHASE RHYTHM DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYO-KEI-ZYUTU-KAN-TO</medicinalproduct>
        <drugdosagetext>7.5 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>0.8 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18620</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALGINAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03645</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18446</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512225-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14261</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007NL18280</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18502</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03322</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>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ANTIDIURETIC HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1800 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>4500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512229-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15061</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>250 MG PO /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACEDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRA PHOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIN-DM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1 GM/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG 1 QID</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>55.7924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>BID X 4 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512236-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00568707</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>DOSE WAS INCREASED UP TO 300 MG PER DAY AND THAN REDUCED IN STEPS TILL IT WAS WITHDRAWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512238-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CICLOPIROX</medicinalproduct>
        <drugbatchnumb>7G28</drugbatchnumb>
        <drugdosagetext>TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN OPTHALMIC 0.3% APOTEX CORP</medicinalproduct>
        <drugbatchnumb>HK7737</drugbatchnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-WYE-G00566007</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512240-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-WYE-H00965707</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDIAL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL EXTENDED-RELEASE</medicinalproduct>
        <drugdosagetext>TWICE TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>TWICE TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512242-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugindication>AUTISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>15MG DAILY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007KR03608</companynumb>
    <primarysource>
      <reportercountry>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (NCH) (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>5 MG/KG, QD</drugdosagetext>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>8.0 MG/KG 3 TIMES DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS (IMMUNOGLOBULINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIRHEUMATIC (INCL.ANTIPHLOGISTICS) (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugbatchnumb>156832B</drugbatchnumb>
        <drugdosagetext>ZOLOFT 150MG TAPER TO ZOLOFT 25MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>102.0593</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR SAGITTAL SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECON</medicinalproduct>
        <drugdosagetext>1 PILL/DAY BY MOUTH TOOK FOR 1.5 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMENORRHOEA</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007AU03629</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>376600</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>14 MG QD TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>376600</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>14 MG QD TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENAC (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.6985</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WAIST CIRCUMFERENCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG WEEKLY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>200MG - TOTAL 1400MG A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666762A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298526</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>6SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668105A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668386A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298525</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>4SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>POSTNASAL DRIP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512254-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668425A</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>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669210A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671266A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673061A</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673087A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR UNKNOWN</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673093A</companynumb>
    <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>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512260-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674734A</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>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298524</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674739A</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>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>6306634</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512262-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676985A</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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677017A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298525</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677047A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677357A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512266-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677754A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>4SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE NASAL SPRAY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677777A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512268-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677868A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512269-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678093A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678094A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512271-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678095A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512272-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678096A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678102A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512274-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678867A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512275-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007CA11473</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>
      <patientweight>99.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX MULTI-ACTION (NCH) (BISMUTH SUBSALICYLATE) SUSPENSION</medicinalproduct>
        <drugbatchnumb>HGK010A</drugbatchnumb>
        <drugdosagetext>3 TSP PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678874A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679678A</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680186A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C299025</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>1TSP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681466A</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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298529</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681472A</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>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681576A</companynumb>
    <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>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681591A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682129A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682421A</companynumb>
    <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>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>22051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512285-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682707A</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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682714A</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>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298526</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682777A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682778A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683054A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683075A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683076A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683321A</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>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>27.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683340A</companynumb>
    <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>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683557A</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>27.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683566A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683838A</companynumb>
    <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 SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683888A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684355A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684370A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684376A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684387A</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>106.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURATUSS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685016A</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>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685310A</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
        <drugbatchnumb>C60CE</drugbatchnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVATOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CC07-182</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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>0107707</drugbatchnumb>
        <drugauthorizationnumb>72273</drugauthorizationnumb>
        <drugdosagetext>ACTUATIONS AS NEEDED</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686006A</companynumb>
    <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686145A</companynumb>
    <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>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686661A</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>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C299027</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEECON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686895A</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>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298524</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>27.5MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686914A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C309069</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687683A</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>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>6306634</drugbatchnumb>
        <drugauthorizationnumb>22051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICKS VAPOR RUB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688035A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688266A</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C303589</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688485A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C298525</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL SINUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688486A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>2SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688516A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512316-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688773A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SNORING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688956A</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>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689275A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512319-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689558A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>C310367</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689793A</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>1SPR PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690072A</companynumb>
    <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>NASAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690084A</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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512323-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690176A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690354A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0691104A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200710AGG00741</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>2.9 ML, 3.2 ML)</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512327-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710USA06042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ IVOMEC PLUS UNK</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugdosagetext>INJ</drugdosagetext>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512328-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000145</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGASON /00530101/ (ETRETINATE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512329-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334316</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>10 PILLS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN P.M. (DIPHENHYDRAMINE CITRATE, PARACETAMOL)</medicinalproduct>
        <drugdosagetext>10 PILLS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>3 PILLS 20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ALCOHOL)</medicinalproduct>
        <drugdosagetext>UP TO SIX BEERS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071100489</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugbatchnumb>6CL3M00</drugbatchnumb>
        <drugdosagetext>TEMPORARY STOP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugdosagetext>TEMPORARY STOP</drugdosagetext>
        <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>MK-0518</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512331-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070905291</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK0518</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR AND RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000262</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>35 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333739</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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugdosagetext>5 TABLETS AT ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05782-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC (ACETYLSALICYLIC LYSINE)</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR (PARACETAMOL/TRAMADOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENSICAL D3 (CALCIUM CARBONATE/COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-GER-05781-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN (LEVOTHYROXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11679</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>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES HARD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN (NCH)(WHEAT DEXTRIN) POWDER</medicinalproduct>
        <drugbatchnumb>22035001</drugbatchnumb>
        <drugdosagetext>2 TSP, TID FOR 5 TO 6 MONTHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20071007130</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</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>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512338-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0707096</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0707096</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100844</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>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX REGIONAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0703767</drugbatchnumb>
        <drugdosagetext>2X 75 UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0703767</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>2X 75 UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER UNKNOWN (NCH)(UNKNOWN) UNKNOWN</medicinalproduct>
        <drugbatchnumb>22111002</drugbatchnumb>
        <drugdosagetext>2 TSP, TAKEN TWICE</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-UKI-05811-01</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL (PARAMOL-118)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL (ISPAGHULA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-SWI-05280-01</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000149</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>50 MG QD</drugdosagetext>
        <drugindication>GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512346-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071101364</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071002410</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000148</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>60 MG QD</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000147</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>60 MG QD</drugdosagetext>
        <drugindication>GLOMERULONEPHRITIS MINIMAL LESION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>60 MG QD</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION (EXCEPT SYRUP), 20.2 </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T07-GER-03683-01</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14100</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL AT ATHLETE'S FOOT CREAM (NCH)(TERBINAFINE HYDROCHLORIDE) CREAM</medicinalproduct>
        <drugauthorizationnumb>20980</drugauthorizationnumb>
        <drugdosagetext>QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEA TREE OIL(MELALEUCA ALTERNIFOLIA OIL)</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060705320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FIBROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART BLOCK CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512353-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070602224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101442</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101564</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>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20071004849</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071002411</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071004147</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000152</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALK_00441_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVITROL</medicinalproduct>
        <drugauthorizationnumb>21897</drugauthorizationnumb>
        <drugdosagetext>380 MG 1X/MONTH INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000151</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>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION (EXCEPT SYRUP), 20.2 </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE101014JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE183211AUG04</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BM000150</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION (EXCEPT SYRUP), 20.2 </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>078-20785-07110057</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07060147</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>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, D1-4, 9-12, 17-20, UNKNOWN</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07051167</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT (IBANDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMT (MOXONIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-01802-SPO-GB</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110268</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0061CB</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG,  1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-01798-SPO-JP</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETICALM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICERGOLINE (NICERGOLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOTO-SAN (CHINESE HERBAL MEDICINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM (BERIZYM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESNATT (DILTIAZEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHIVORAN (DISOPYRAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYORIN-AP (KYORIN AP 2)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAKUBAN (FLURBIPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAROYCIN (CLARITHROMYCIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512372-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110210</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110158</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-01792-SPO-DE</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>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512375-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06090414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, DAYS 1-21 EVERY 28 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, DAILY, DAYS 1-4, 9-12, 17-20 EVERY 28D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07091599</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0060CB</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07090912</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512378-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07071710</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07030244</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007UA18491</companynumb>
    <primarysource>
      <reportercountry>UKRAINE</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugauthorizationnumb>021302</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101792</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0060C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0060C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0060C-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL, 5 MG 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL, 5 MG 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512384-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRACCO-BRO-012241</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>1.5 ML/SEC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugdosagetext>1.5 ML/SEC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUNACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OIF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>120 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512386-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>1-25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07100909</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512388-9</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07110120</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-03158-01</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECONIUM IN AMNIOTIC FLUID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERVIDIL</medicinalproduct>
        <drugauthorizationnumb>20411</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHITOSAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAPAK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T07-USA-05790-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE (DOUBEL BLIND) (MEMANTINE)</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E (VEGETABLE OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A / BETA CAROTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM, VIT D, MAGNESIUM, ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENTAL CLARITY (MUSHROOM EXTRACT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POMEGRANATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIESTA(HERBAL SUPPLEMENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239398K07USA</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512392-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071102990</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>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>229-C5013-07061537</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>ORAL ; 20 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>ORAL ; 20 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230223M07USA</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS,</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS,</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS,</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238820K07USA</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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT (INFLUENZA VIRUS VACCINE POLYVALENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-TYCO HEALTHCARE/MALLINCKRODT-T200701381</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512397-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512399-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>440025M07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTIS CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROSTIM</medicinalproduct>
        <drugauthorizationnumb>20604</drugauthorizationnumb>
        <drugindication>CACHEXIA</drugindication>
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  <safetyreport>
    <safetyreportid>5512400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2020-01792-SPO-DE</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
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        <drugstartdate>20030101</drugstartdate>
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        <drugenddate>20070501</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
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    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
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    <receiptdate>20071024</receiptdate>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
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        <drugenddate>20070215</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, INTRAMUSCULAR; 80 MG INTRAMUSCULAR ; 83 MG INTRAMUSCULAR ; 87 MG INTRAMUSCULAR ; 95 MG INTRA</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, INTRAMUSCULAR; 80 MG INTRAMUSCULAR ; 83 MG INTRAMUSCULAR ; 87 MG INTRAMUSCULAR ; 95 MG INTRA</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, INTRAMUSCULAR; 80 MG INTRAMUSCULAR ; 83 MG INTRAMUSCULAR ; 87 MG INTRAMUSCULAR ; 95 MG INTRA</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>100 MG, INTRAMUSCULAR; 80 MG INTRAMUSCULAR ; 83 MG INTRAMUSCULAR ; 87 MG INTRAMUSCULAR ; 95 MG INTRA</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RESPIRATORY SYNCYTIAL VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5512402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN (ESTROGEN NOS)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT (SERTRALINR HYDROCHLORIDE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
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    </patient>
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    <safetyreportid>5512403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5512404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071026</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>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.0198</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>19764</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, 1 IN 1 DAYS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, 1 IN 2 DAYS, ORAL</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
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      <drug>
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        <medicinalproduct>CORTEF</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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    <safetyreportid>5512405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061004</drugenddate>
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  <safetyreport>
    <safetyreportid>5512406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</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>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
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        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
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  <safetyreport>
    <safetyreportid>5512407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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        <drugstartdate>20070927</drugstartdate>
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      <drug>
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        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
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      <drug>
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      <drug>
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        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
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      <drug>
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        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
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      <drug>
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        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
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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>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>CLARAVIS</medicinalproduct>
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        <drugdosagetext>40 MG, QD, ORAL; 80 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010801</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>77873</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020264</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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071004421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512413-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070704217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>PATIENT RECEIVED A TOTAL OF 24 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugdosagetext>^15/WK^</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512414-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0544937A</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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050207</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0548597A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512416-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0591684A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>.5TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0596728A</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>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>Y345A63</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <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>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0596809A</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>109.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051220</drugenddate>
        <drugtreatmentduration>342</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623257A</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>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623738A</companynumb>
    <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1000MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624038A</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>106.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624393A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624745A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <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>20060801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625089A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625355A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626187A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>2296A64</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071101</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010799</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugdosagetext>250 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626219A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TABD PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626328A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626331A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYNASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626442A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626582A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512433-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626742A</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627264A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628100A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628166A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628713A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628830A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628865A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630317A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630511A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631720A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632297A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632630A</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632631A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061224</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633746A</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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634725A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634742A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635174A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635688A</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>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635860A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636508A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636741A</companynumb>
    <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>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637409A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638331A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639720A</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>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639721A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640038A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640103A</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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640287A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640766A</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641166A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641493A</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 FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641914A</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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641925A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642138A</companynumb>
    <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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643218A</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>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOR-QD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643248A</companynumb>
    <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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643558A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>6ZP4606</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643694A</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>6ZP4615,6ZP1117</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060318</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644269A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLEEPING PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645056A</companynumb>
    <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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647436A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZP6679</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512475-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647636A</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 INSULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647830A</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648558A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648783A</companynumb>
    <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>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>.5TAB UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648877A</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>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649082A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070331</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649091A</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>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512482-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649265A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649977A</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>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650112A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650129A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650898A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651610A</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651755A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZP7759</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>.5TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652185A</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>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652354A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652385A</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652387A</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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652397A</companynumb>
    <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>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652436A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652496A</companynumb>
    <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>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652607A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>ROSACEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652632A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>2656A67</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652646A</companynumb>
    <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>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652647A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652668A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652694A</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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652858A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652904A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653030A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653233A</companynumb>
    <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653411A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653496A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653703A</companynumb>
    <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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653706A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MGML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653815A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>Y415A63</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654065A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>71524</drugauthorizationnumb>
        <drugdosagetext>1 TO 4 TABLET(S), HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654069A</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654288A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654289A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654405A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>529203</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654412A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654441A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654595A</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>115.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZPO405</drugbatchnumb>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654601A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>8 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654626A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTAL PLUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654630A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZP0406</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655057A</companynumb>
    <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTATE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655896A</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>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656598A</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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656647A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658224A</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>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658233A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659216A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659669A</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZP1301</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660736A</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>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512533-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663991A</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663993A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663996A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664300A</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>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL GENTLEHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664840A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665284A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665290A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665407A</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>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667082A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667636A</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>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668660A</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>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668700A</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>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669802A</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>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669805A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673037A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676643A</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDARYL</medicinalproduct>
        <drugauthorizationnumb>021700</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677741A</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>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680176A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>6ZP7262</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCODAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681479A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>2TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681863A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682749A</companynumb>
    <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683043A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683944A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>7ZP7763</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684357A</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>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684713A</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686905A</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>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686937A</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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FEI2007-1871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAGARD T 380A</medicinalproduct>
        <drugauthorizationnumb>18680</drugauthorizationnumb>
        <drugdosagetext>INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010798</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>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>76071</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACOMPLIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010749</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76671</drugauthorizationnumb>
        <drugdosagetext>50 MG;</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
        <drugauthorizationnumb>20336</drugauthorizationnumb>
        <drugdosagetext>5 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugauthorizationnumb>20631</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugauthorizationnumb>018163</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL                            /00002101/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070902084</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC ARTHRITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007103</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugdosagetext>DOSE: 3 PAC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101396</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022273</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>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>96 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071004467</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>LYMPHOCYTIC HYPOPHYSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <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>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATIONS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP016448</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>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12158</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.8 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIAN ZHU LI YE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECOMBINANT HUMAN ERYTHROPOIETIN (RHUEPO)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5512573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230012M07ISR</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
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  <safetyreport>
    <safetyreportid>5512574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230007M07ITA</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBINED ORAL CONTRACEPTIVE (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5512575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010673</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>75876</drugauthorizationnumb>
        <drugdosagetext>20 MG;DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
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        <drugenddate>20070829</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCOPOLAMINE BUTYL BROMIDE (NO PREF. NAME)</medicinalproduct>
        <drugdosagetext>20 MG;AS NEEDED;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010636</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>74587</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009368</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>74587</drugauthorizationnumb>
        <drugdosagetext>6 GM; X1</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100725</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007001759</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100585</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>137</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20061001537</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <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>
        <drugdosagetext>UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION REPORTED AS OD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOIOGITO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710000095</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>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200609005597</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>250 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031214</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE16690</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25564</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>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25780</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>URETERIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2006-02525</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>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>O2382A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>O2382A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060606</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007001866</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRON (ONDANSETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002017</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002026</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200715723GDDC</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>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugdosagetext>DOSE: 62 MG AS TOTAL DOSE ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 250 AS TOTAL DOSE ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-007658-07</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002023</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>4340 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>290 MEV</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE HCL</medicinalproduct>
        <drugdosagetext>0.25MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>4.8 MG TWICE 4 HRS APART IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10729</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>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>AO195</drugbatchnumb>
        <drugdosagetext>1MG 2X A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10728</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>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GETUZUMAB OZOGAMICIN</medicinalproduct>
        <drugindication>MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>103.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01783_2007</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN SYRUP</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>DF-SEVERAL PEDIATRIC DOSES</drugdosagetext>
        <drugindication>EAR PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1230MG IV EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1230MG IV EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1230MG IV EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1230MG IV EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>50 MG/M2 DAILY X28DAYS</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOKATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG 1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>960 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOSTATIN</medicinalproduct>
        <drugdosagetext>6.4 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>90.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SOLVAY-00207034799</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>695</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREXUM</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREXUM</medicinalproduct>
        <drugauthorizationnumb>020184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFASOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURESIS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423320-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALUTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP006244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD8 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC, 60 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC, 60 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO, 600 MG; QD; PO, 400MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO, 600 MG; QD; PO, 400MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO, 600 MG; QD; PO, 400MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRIXIVAN /01304201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESPO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>73.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUPIROCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20070704021</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENIC T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>INTERMITTENT USAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007529</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>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <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>ISCOTIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CI PLUS EPHE GYPSU-SUPO</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200616063GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE CREAM 1.%</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>106.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>137.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>93.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>108.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>154.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.0072</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG 1 A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG 1 A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019900</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOXAFIL</medicinalproduct>
        <drugauthorizationnumb>22003</drugauthorizationnumb>
        <drugdosagetext>200 MG; QID; PO, 200 MG; TID; PO, 400 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOXAFIL</medicinalproduct>
        <drugauthorizationnumb>22003</drugauthorizationnumb>
        <drugdosagetext>200 MG; QID; PO, 200 MG; TID; PO, 400 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIUM /00031402/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN /00039501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBAC /01173601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIC /00587301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC /00082801/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELOMYRTOL FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOK ZOK MITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101026</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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM ER</medicinalproduct>
        <drugauthorizationnumb>021692</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE ER</medicinalproduct>
        <drugauthorizationnumb>021692</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>00002701</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL HCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugbatchnumb>00142201</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040905780</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</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>LOXONIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE = 3 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>0.3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>3 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 0.75RG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEISHI KARYO NINJIN BUTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019744</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>10E20071572</companynumb>
    <primarysource>
      <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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATULINE DEPOT</medicinalproduct>
        <drugauthorizationnumb>22074</drugauthorizationnumb>
        <drugdosagetext>60 MG (60MG, 1 IN 1 M) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM MATRIXX</medicinalproduct>
        <drugdosagetext>1 DOSE ONCE NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY WEIGHT SMART ADVANCED VARIOUS BAYER HEALTHCARE</medicinalproduct>
        <drugbatchnumb>7FA0873</drugbatchnumb>
        <drugdosagetext>1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010812</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76122</drugauthorizationnumb>
        <drugdosagetext>30 MG;</drugdosagetext>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76122</drugauthorizationnumb>
        <drugdosagetext>30 MG;</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1 MG;</drugdosagetext>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1 MG;</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200711057BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>AS USED: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716752GDS</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION SR 150 MG. TEVA</medicinalproduct>
        <drugbatchnumb>00093-5502-01</drugbatchnumb>
        <drugdosagetext>150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION SR 150 MG. TEVA</medicinalproduct>
        <drugbatchnumb>G/2444</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010813</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>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>74732</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>73.4827</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>40 MGM TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>105181</drugbatchnumb>
        <drugdosagetext>UP TO 2 TABS DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>147.419</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugbatchnumb>NOT ON FILE</drugbatchnumb>
        <drugdosagetext>100MCG 15+ DAILY INHAL 6 MONTHS C NO RESULTS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEAU D'ORANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 250 MG/M^2</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE 1250 MG</medicinalproduct>
        <drugdosagetext>BID FOR DAYS 1-14</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>EVERY 3 WEEKS</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GDP-07403129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBEX</medicinalproduct>
        <drugauthorizationnumb>21644</drugauthorizationnumb>
        <drugdosagetext>(TOPICAL)</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ACO_00395_2007</companynumb>
    <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>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugauthorizationnumb>20397</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>(DF INTRATHECAL)</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOCPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BRACCO-BRO-012301</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL MYELOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021533</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>1600 UG TID BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>1600 UG TID BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>75 UG Q72HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>75 UG Q72HR TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010818</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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugdosagetext>250 MG; ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT /01033501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>A13437</drugbatchnumb>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01773_2007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPERFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN (DOXEPIN)</medicinalproduct>
        <drugauthorizationnumb>71422</drugauthorizationnumb>
        <drugdosagetext>(4000 MG NOT THE PRESCRIBED AMOUNT)</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>(100 MG NOT THE PRESCRIBED AMOUNT)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022050</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;SC; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;SC; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>;PO ;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>;PO ;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250937</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>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30804_2007</companynumb>
    <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>(120 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>(500 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>(500 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>(750 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 TRIGLYCERIDES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11177</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>6.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENE MUTATION IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEISSERIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018686</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>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;QW;SC; QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;QW;SC; QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021800</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5 ML; SC; 0.3 ML;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5 ML; SC; 0.3 ML;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5 ML; SC; 0.3 ML;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008811</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPRANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971700</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13937487</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTICAINE HCL</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13977723</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022270</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugbatchnumb>5-DCW-33</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12273</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 SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>1.6 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10494</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>MG  IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP016760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG;QD;PO; 800 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON (PEGINTERFERON ALAF-2B)</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12309</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>3 UNITS TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13969332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13974555</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200MG/DAY FROM JULY 2007.</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOGIMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13969985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13868724</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugtreatmentduration>69</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>20070525</drugstartdate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13977582</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
        <drugdosagetext>THE PATIENT WAS TREATED WITH METFORMIN+GLIBENCLAMIDE (2.5 MG/500) 5-DOSAGE FORMS /DAY SINCE APR-07</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100564</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>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071100864</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071003347</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>NON-HODGKIN'S LYMPHOMA STAGE III</reactionmeddrapt>
      </reaction>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIPARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070900636</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <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>4 INFUSIONS ON UNSPECIFIED DATES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070904874</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20071101495</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>SECOND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST DOSE IN SUMMER-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101563</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>6JFL10</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75 MG/J2;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022182</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>50 MCG, BID;NAS</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30656_2007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(25 MG 1X NOT THE PRESCRIBED AMOUNT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROTHIXENE (CHLORPROTHIXENE) 50 MG</medicinalproduct>
        <drugdosagetext>(600 MG 1X NOT THE PRESCRIBED AMOUNT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>3600 MG 1X NOT THE PRESCRIBED AMOUNT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0710S-0438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30753_2007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>(NOT THE PRESCRIBED AMOUNT ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>150 MG 1X NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>(250 MG 1 X NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>(35 MG 1X NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (VODKA - ETHANOL)</medicinalproduct>
        <drugdosagetext>(NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOSIL /00133602/ (ATOSIL - ISOPROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>(NOT THE PRESCRIBED AMOUNT. ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-13974571</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071100765</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0221</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>8 ADMINISTRATIONS FOR A CUMULATIVE DOSE OF 160 ML; LAST DOSE WAS 20 ML, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01774_2007</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOPRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76093</drugauthorizationnumb>
        <drugdosagetext>(400 MG QD)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0222</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>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>20 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01788_2007</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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 GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOPRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76093</drugauthorizationnumb>
        <drugdosagetext>(400 MG QD INTRAVENOUS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYELONEPHRITIS ACUTE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>20 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-248172</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>60 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0224</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>4 ADMINISTRATIONS FOR A CUMULATIVE DOSE OF 200 ML; LAST DOSE WAS 60 ML, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0217</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>20 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0218</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>20 ML, SINGLE DOSE, I.V.; 20 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02250</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>2.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN INFANT DEATH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25698</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>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED UPPER AIRWAY SECRETION</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPHAGIA</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW08650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>5 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATIONS, MIXED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THORAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW19470</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>82.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</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>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ASTRAZENECA-2006AC00662</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>3 ADMINISTRATIONS FOR A CUMULATIVE DOSE OF 60 ML; LAST DOSE WAS 20 ML, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0220</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>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>20 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-163464-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>21529</drugauthorizationnumb>
        <drugdosagetext>NON-US INSERTION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0705S-0216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>4 ADMINISTRATIONS FOR A CUMULATIVE DOSE OF 80 ML; LAST DOSE WAS 20 ML, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
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    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14478</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>68.027</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-07P-090-0415742-00</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMOCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#4#2007-00153</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>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>6MG/24H, 1 IN 1 D, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISTRADEFYLLINE (KW-6002)</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTACAPONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021430</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>76.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>0.25 MG/KG  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023134</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>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
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        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5512720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BULIMIA NERVOSA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>30 UG;QW;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5512721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
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    <receiptdate>20071024</receiptdate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.7705</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020745</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>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68021</drugbatchnumb>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP006457</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>71.2147</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG;QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007MP000499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIADEL</medicinalproduct>
        <drugauthorizationnumb>20637</drugauthorizationnumb>
        <drugdosagetext> ;X1;ICER</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003610</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>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>2 MG; TIW; ORA; ; 2 MG; HS; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>2 MG; TIW; ORA; ; 2 MG; HS; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>232687K07USA</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>COLON CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN ER (OXYCODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239280K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-528385</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE-35</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-529019</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-525626</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SAPHO SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>EQUIVALENT TO 0.5 MG/KG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE REDUCED OVER 6 WEEKS THEN STOPPED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>60890</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>44.9061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>75598</drugauthorizationnumb>
        <drugdosagetext>1ML/DAILY/TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISHI OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHMA INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239214K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22 MCG, 2 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239317K07USA</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2003149797US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:216MG-FREQ:ON DAY 1 AND 8 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugbatchnumb>RCT 12246</drugbatchnumb>
        <drugdosagetext>DAILY DOSE:400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRUCIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:86.5MG-FREQ:ON DAY 1 AND 8 EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:34MG-FREQ:CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-529617</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>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIZOTIFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-511627</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>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH REPORTED AS 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH REPORTED AS 10 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH REPORTED AS 10 MG, PATIENT MISSED DOSAGE FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugdosagetext>DRUG NAME: DIANE 35</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-501761</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE FULMINANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SAPHO SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>EQUIVALENT TO 0.5 MG/KG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-528382</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-529297</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-528419</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugdosagetext>FORM: VIAL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>FORM: VIAL.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-524351</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>43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMPLANT SITE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>DRUG NAME: ALFASULY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugdosagetext>DRUG NAME: SOLDEM 3A (MAINTENANCE MEDIUM)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-523021</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 4 FEBRUARY 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>THERAPY PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 16 APRIL 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>THERAPY PERMANENTLY DISCONTINUED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>050723</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE RECEIVED ON 16 APRIL 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>REPORTED AS METHYLPREDNISONE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>1000MG EVERY OTHER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - FOLIC ACID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - FERRUM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YECTAFER</medicinalproduct>
        <drugdosagetext>REPORTED AS YECTAFER COMPLEX - VITAMIN B12</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS CALCIUM BICARBONATE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS 300000 UI.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-498377</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>BUNION OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROURETER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>THERAPY IN THE MID TO LATE 1980'S.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-496306</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS CO-TRIMOXAZOLE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETRIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-485892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ. STRENGTH REPORTED AS 3-10 MG/CC.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07100</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP03730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33217</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELIFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMETA</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIETEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHA-JINKI-GAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLON</medicinalproduct>
        <drugdosagetext>FINE GRAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT-U</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREPEARL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC PREPARATIONS ACTING MAINLY ON GRAM POSITIVE BA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239259K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN 24 (ANOVLAR)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07101</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-511003</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-02707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIORETINAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIORETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>80356</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239026K07USA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04886</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>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>63083</drugauthorizationnumb>
        <drugdosagetext>900 MG, Q8H, INTRAVENOUS; 300 MG, Q6H, ORAL</drugdosagetext>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>63083</drugauthorizationnumb>
        <drugdosagetext>900 MG, Q8H, INTRAVENOUS; 300 MG, Q6H, ORAL</drugdosagetext>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAL VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163468USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugauthorizationnumb>77445</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPOSITIONAL DEFIANT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINOCEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1.5 MG 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.25 MG 1/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1.125 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>850 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13972179</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>
      <patientweight>130</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>20972</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13973219</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>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>ON 21-OCT-2007 TO 27-OCT-2007 3 MG. ON 28-OCT-2007 TO 28-OCT-2007 WAS INCREASED TO 6 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPERICIAZINE</medicinalproduct>
        <drugdosagetext>TILL 27-OCT-2007 25 MG. ON 28-OCT-2007 10 MG. ON 29-OCT-2007 ONGOING 25 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971072</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>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-13969951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN TABS</medicinalproduct>
        <drugauthorizationnumb>21360</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13971536</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>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239302K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238622K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.4608</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239290K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC NEOPLASM UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002322</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL (LISINOPRIL DIHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239031K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN /00082701/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/TRIAMTERENE (DYAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002712</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPRYCEL (KETANSERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE (TRAZODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-AMGEN-US176339</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </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>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019081</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>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD</medicinalproduct>
        <drugdosagetext>16 DF; ; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD</medicinalproduct>
        <drugdosagetext>16 DF; ; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL DRUG MISUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN</medicinalproduct>
        <drugdosagetext>20 DF; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200714173GDS</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHROMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506-OINTMENT (TACROLIMUS OINTMENT) FK506 - OINTMENT(TACROLIMUS) OINT</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>0.1 %, BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US247794</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>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR17821</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugdosagetext>12 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17805</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-US108822</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-AMGEN-US108821</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>^25 Y^ TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163246ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>61926</drugauthorizationnumb>
        <drugdosagetext>(1000 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOMEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163271ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCADIAN RHYTHM SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>70035</drugauthorizationnumb>
        <drugdosagetext>600 MG (200 MG,3 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713476FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISCOTRINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMANDOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00789001/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713538FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON                         /00023503/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713540FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMIGOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN                          /00789001/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AVENTIS-200715206EU</companynumb>
    <primarysource></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>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-AVENTIS-200715162EU</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016363</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>28000423</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200714845EU</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>76.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN                             /00041901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CP-751, 871 (INVESTIGATIONAL DRUG)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CP-751, 871 (INVESTIGATIONAL DRUG)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CP-751, 871 (INVESTIGATIONAL DRUG)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200715179EU</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>HAEMATOMA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200715742US</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020786</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX235151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D074264,P095193</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US251548</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163236ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76119</drugauthorizationnumb>
        <drugdosagetext>(30 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATED DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>(1 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATED DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6020768</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>1.25 MG (1.25 MG,1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>3.125 MG (3.125 MG,1 IN 1 D) ; 6.25 MG (6.25 MG,1 IN 1 D) ONLY FOR 1 DAY -</drugdosagetext>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6039115</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG,1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#01#2007-03606</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMAMED FORTE (AZITHROMYCIN) (AZITHROMYCIN)</medicinalproduct>
        <drugauthorizationnumb>65246</drugauthorizationnumb>
        <drugdosagetext>10MG/KG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFERON (ANAFERON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEX (LACTOBACILLUS ACIDOPHILUS) (LACTOBACILLUS ACIDOPHILUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04353</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORANEX (AZITHROMYCIN) (AZITHROMYCIN)</medicinalproduct>
        <drugauthorizationnumb>65223</drugauthorizationnumb>
        <drugdosagetext>500 MG ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRIPEX NOC (PARACETAMOL, PSEUDOEPHEDRINE, DEXTROMETHORPHAN)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENARENAL (ENALAPRIL MALEATE) (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOZEK (AMLODIPINE) (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALDYUM (POTASSIUM CHLORIDE) (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPEN (INDAPAMIDE) (INDAPAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE B6 (MAGNESIUM, PYRIDOXIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>107#03#2007-04242</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76307</drugauthorizationnumb>
        <drugdosagetext>30 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATED DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATED DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002277</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>7E2049</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>4.5 GM (2.25 GM, 2 IN 1 D), ORAL; 6 GM (3 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND PARACETAMOL (PARACETAMOL W/TRAMADOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002382</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>(40 MG, Q8HRS)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12 (CYANOCOBALAMIN-TANNIN COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN /00831701/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL (LINUM USITATISSIMUM SEED OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE/TESTOSTERONE (ESTROGEN W/TESTOSTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019877</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>250 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>59 MG; ; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX /00340101/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL /00790701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020180</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>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>135 MCG; QW; SC, 120 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>135 MCG; QW; SC, 120 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1200 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07-002097</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugauthorizationnumb>21852</drugauthorizationnumb>
        <drugdosagetext>0.005 %, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713559BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER EFFERVESCENT PLUS NIGHT TIME COLD</medicinalproduct>
        <drugbatchnumb>A7F20C</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01666</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISICOL</medicinalproduct>
        <drugauthorizationnumb>21097</drugauthorizationnumb>
        <drugdosagetext>50G (50TAB), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOSCOPY LARGE BOWEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01667</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugauthorizationnumb>21881</drugauthorizationnumb>
        <drugdosagetext>1 LIT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022208</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>58.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOMEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04334</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77299</drugauthorizationnumb>
        <drugdosagetext>100MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST (CILEST) (ETHINYLESTRADIOL, NORGESTIMATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0686</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-EUR-07-0151</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-1164465</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>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugauthorizationnumb>18469</drugauthorizationnumb>
        <drugdosagetext>INTRAOCULAR</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CATARACT OPERATION COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISCOAT</medicinalproduct>
        <drugdosagetext>INTRAOCULAR</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>FOR 2-3 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007139</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH CALORIE INFUSION</medicinalproduct>
        <drugindication>MALNUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>SECOND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-438845</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>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</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>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>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>5512821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-1164180</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACHROMOTRICHIA ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTERIOR CHAMBER CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA OF EYELID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPOPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITILIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugauthorizationnumb>61648</drugauthorizationnumb>
        <drugdosagetext>TID TO THE EYE AND SUTURED INCISION OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>1 TABLET WITH BREAKFAST PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-166208-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL</medicinalproduct>
        <drugauthorizationnumb>21529</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>7.5MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2007A01056</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>1 DOSE 1 X PER 1 TOT, 1 DOSE 1 X PER 1 TOT</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>1 DOSE 1 X PER 1 TOT, 1 DOSE 1 X PER 1 TOT</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>1 DOSE 1 X PER 1 TOT, 1 DOSE 1 X PER 1 TOT</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOSAN POLYSULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>69R002F</drugbatchnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORMAL SALINE PREFILLED SYRINGE 3 ML IN 10 CC SYRINGE HOSPIRA</medicinalproduct>
        <drugbatchnumb>53-024-9D</drugbatchnumb>
        <drugdosagetext>3 ML PRN FLUSH IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>FLUSHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORMAL SALINE PREFILLED SYRINGE 3 ML IN 10 CC SYRINGE HOSPIRA</medicinalproduct>
        <drugbatchnumb>51-047-9D</drugbatchnumb>
        <drugdosagetext>3 ML PRN FLUSH IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>FLUSHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.0072</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG 1 A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG 1 A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#8#2007-00306</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>20649</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75MG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75MG ONCE A DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMCITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>N62942</drugbatchnumb>
        <drugdosagetext>375MG/M2 --} 660MG FOR THIS PT ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>N77566</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>1 PILL FOR 28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>1 PILL FOR 28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>1 PILL FOR 28 DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>104</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>700 MG, BID (ALL 3 --)</drugdosagetext>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>500 MG,BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001</medicinalproduct>
        <drugdosagetext>2.5MG QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</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>5512834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>87.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>82.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>85.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0662</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512841-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512842-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512843-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>85.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512844-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-WYE-H01041607</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00978807</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>1600 UG 5-6 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>400 UG UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245534</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/KG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>100 MG/M2, DAYS1,8,15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>40 MG, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERGAN FORTIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>119.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GENENTECH-246417</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>8 MG/M2, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>520 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>170 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>190 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>11.4 MG, X2</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0663888A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0686408A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>18612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690239A</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>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7C19B</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692002A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693090A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693106A</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>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693106B</companynumb>
    <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512861-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693121A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693534A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693670A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>1PAT PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693737A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693800A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494628A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ CLEAR 14MG</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>14MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINELL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-250768</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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>8 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG/M2, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0661</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512871-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493814A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UREAPLASMA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN (FORMULATION UNKNOWN) (GENERIC) (MELPHALAN)</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY (FORMULATION UNKNOWN) (RADIOTHERAPY)</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (FORMULATION UNKNOWN) (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>375 MG/M2 WEEKLY</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID (FORMULATION UNKNOWN) (CORTICOSTEROID)</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONODINE PATCHES</medicinalproduct>
        <drugdosagetext>ONE PATCH ONE EVERY WEEK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>PANAMA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>0057067</drugbatchnumb>
        <drugdosagetext>150 1 AT NIGHT 1 NIGHT. NO MORE, PLS</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>OBESITY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512875-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0606407A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0640660A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOFOAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512877-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0647030A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPLENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VEIN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SITUS INVERSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0668130A</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>58.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>ZP06884</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL PATCHES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0673896A</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>53.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0683130A</companynumb>
    <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>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>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0683131A</companynumb>
    <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>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0435966A</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>
      <patientweight>63.8665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000 MG PER DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687563A</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>90.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>7ZP1879</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688348A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>558</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGESTIVE ENZYMES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL FOOT MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HAND MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>400MG ONCE A DAY PO EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688747A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689545A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691462A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>X6924</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</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>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691486A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512890-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691705A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>7ZP4934</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691706A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691721A</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>CORNEAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692258A</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693642A</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693648A</companynumb>
    <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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693684A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAWASAKI'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugauthorizationnumb>021515</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693975A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0056566A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020103</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980502</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0057562A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980503</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>1MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE</medicinalproduct>
        <drugdosagetext>1MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0472112A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAUROMACROGOL 400</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060415</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0476875A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugauthorizationnumb>21652</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OPPORTUNISTIC INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485301A</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>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487666A</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>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>1.34MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>89.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490969A</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>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVASTAL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDYS</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>3.75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491140A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE EYE BLINKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>510</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492446A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>418</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROPENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>312</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>405</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493503A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINORDIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493649A</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>
      <patientweight>153</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20671</drugauthorizationnumb>
        <drugdosagetext>3.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>138MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494122A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494356A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>500MG WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050620</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494360A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>100</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494481A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494568A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494595A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>019389</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>400MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADALAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494631A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE DISKUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20833</drugauthorizationnumb>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-TILDIEM 120 MG</medicinalproduct>
        <drugdosagetext>120MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>1PAT PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494732A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION MUCOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>175MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>175MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>8740MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494778A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494786A</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugdosagetext>115MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020596</drugauthorizationnumb>
        <drugdosagetext>45MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>1.8ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494819A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494841A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINNAT INJECTABLE</medicinalproduct>
        <drugauthorizationnumb>50558</drugauthorizationnumb>
        <drugdosagetext>1INJ SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLUVEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494905A</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONDAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050319</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494913A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>4000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALS</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEPROTON</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARATOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREMIS</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494917A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054910A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DROP ATTACKS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELONTRIL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>100MG IV ONCE DAY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>100MG IV ONCE DAY</drugdosagetext>
        <drugindication>VIRAL MYOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>100MG IV ONCE DAY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>100MG IV ONCE DAY</drugdosagetext>
        <drugindication>VIRAL MYOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONESTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07147</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE:DISKUS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTANOL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHYLLIN M</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOTEC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE06003</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>55.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFED</medicinalproduct>
        <drugdosagetext>25MG TEST DOSE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512929-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>7.5 MG  DAILY  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOSAR</medicinalproduct>
        <drugdosagetext>180 MG IV IN 500ML D5W/.45% NS  1X  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>.5 MG   1X-2X DAY WEEK 1  PO;  1 MG  2X DAY - WEEK 2 ON  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>.5 MG   1X-2X DAY WEEK 1  PO;  1 MG  2X DAY - WEEK 2 ON  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WALPHED, GENERIC SUDAFED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13904701</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>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13851175</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RESTARTED ON 04-JUL-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>RESTARTED ON 04-JUL-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>RESTARTED FROM 04-JUL-2007</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13696737</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>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>9218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512935-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13974597</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>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>SECOND COURSE GIVEN ON 23-APR-2007</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512936-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13974514</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>170MG\COURSE ON DAY1, DAY8, DAY15 STARTING 03-JUL-07 TO 28-AUG-07</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>950MG\COURSE ON DAY 1 AND DAY 15 FROM 03-JUL-07 TO 15-AUG-2007</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US238692</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512938-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13973110</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>THE FIRST COURSE WAS PERFORMED ON 14-AUG-2007 AT THE DOSE OF 60MG/M2</drugdosagetext>
        <drugindication>ANGIOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13974704</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13973714</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13977400</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>070867</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL ALLERGY COMPLETE</medicinalproduct>
        <drugbatchnumb>JSF 098</drugbatchnumb>
        <drugdosagetext>2 TABLETS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL SINUS CONGESTION + PAIN</medicinalproduct>
        <drugbatchnumb>MBM105</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512943-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0060C-B</drugbatchnumb>
        <drugdosagetext>15MG  QD TO QOD UD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLERAN</medicinalproduct>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US234274</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>TRANSITIONAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG WEEKLY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-US251297</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <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>ENBREL</medicinalproduct>
        <drugauthorizationnumb>005088</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA00823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050606</drugenddate>
        <drugtreatmentduration>1138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0709USA03383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</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>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0711ESP00010</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA03902</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>065</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>5512951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05058</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060626</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL D</medicinalproduct>
        <drugadministrationroute>065</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>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512952-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00547</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>CRIXIVAN</medicinalproduct>
        <drugauthorizationnumb>020685</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512953-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00786</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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512954-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0703FRA00092</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>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512955-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA00431</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLINZA</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA02562</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA06047</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0708USA05124</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA01912</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E NICOTINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA03279</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PENETRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003JP04764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS SEROLOGY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14440</companynumb>
    <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>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AMGEN-UK231842</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710585BYL</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US246844</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>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-US228719</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071006001</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US213509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US251556</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512970-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-US251551</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>} 12.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US224229</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>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>UNSPECIFIED JEL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED TAP</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-US251554</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</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>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>SINCE 3 YEARS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-AMGEN-US251617</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNONWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512974-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US221916</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060205</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060816</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060816</drugenddate>
        <drugtreatmentduration>979</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugtreatmentduration>979</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDOMETHINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILTAX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRSOGLADINE MALEATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX 23</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0059C-A</drugbatchnumb>
        <drugdosagetext>10MG  DAILY  PO;  10MG  EVERY 3 DAYS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0059C-A</drugbatchnumb>
        <drugdosagetext>10MG  DAILY  PO;  10MG  EVERY 3 DAYS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.0802</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS STOOLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugdosagetext>1 CAPSULE EVERY 8 HOURS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX250560</companynumb>
    <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CYST BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX250565</companynumb>
    <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 LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086320</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712308BCC</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>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>238546P</drugbatchnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 325 MG  UNIT DOSE: 325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250839</companynumb>
    <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU249817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P092041</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493634A</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugauthorizationnumb>20977</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIRETROVIRAL MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX248615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512984-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D092239</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX248688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRODESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P068341</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P068341</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANEXSIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249179</companynumb>
    <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 CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D085516</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D085516</drugbatchnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX244485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US206731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW24182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOCATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25885</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>96.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21957</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512992-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25593</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>IB2042</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugdosagetext>180 UG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25907</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, UNSPECIFIED TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US251745</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>NIPPLE EXUDATE BLOODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-200716425GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710180BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250721</companynumb>
    <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 CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5512999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13977764</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>CUMULATIVE DOSE: 1700 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13977012</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250723</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513002-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13975032</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513003-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-13975321</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugauthorizationnumb>060517</drugauthorizationnumb>
        <drugdosagetext>INTRACAMERAL INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>KERATITIS FUNGAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717763US</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>EQ24</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE EYE DROPS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717792US</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>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>N057</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC AGENTS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720256GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717901US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200717321GDDC</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUTOPEN INSULIN INJECTION PEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712881JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUICK ACTING INSULIN</medicinalproduct>
        <drugdosagetext>FREQUENCY: BEFORE MEALS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US251217</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713340BCC</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>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY WOMENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE A DAY WOMENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 325 MG  UNIT DOSE: 325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US247482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US244310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US250669</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</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>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA_2007_0029870</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>SENSORY DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493682A</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRODUCT TRANSFUSION DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULPHAN (FORMULATION UNKNOWN) (GENERIC) (BUSULFAN)</medicinalproduct>
        <drugauthorizationnumb>9386</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABBIT ANTITHYMOCYTE IMMU (FORMULATION UNKNOWN) (RABBIT ANTITHYMOCYTE </medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS (FORMULATION UNKNOWN) (TACROLIMUS)</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (FORMULATION UNKNOWN) (MYCOPHENOLATE MOFETIL)</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (FORMULATION UNKNOWN) (OXYGEN)</medicinalproduct>
        <drugindication>CYSTITIS HAEMORRHAGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0417281-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FINGER REPAIR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL XS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493776A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULPHAN (FORMULATION UNKNOWN) (GENERIC) (BUSULFAN)</medicinalproduct>
        <drugauthorizationnumb>9386</drugauthorizationnumb>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>LYMPHOHISTIOCYTOSIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0545274A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOSITUMOMAB</medicinalproduct>
        <drugbatchnumb>011036</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODINE I 131 TOSITUMOMAB</medicinalproduct>
        <drugbatchnumb>011037/011068</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOSITUMOMAB</medicinalproduct>
        <drugbatchnumb>011036</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010808</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODINE I 131 TOSITUMOMAB</medicinalproduct>
        <drugbatchnumb>011037/011072</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010808</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE226101SEP05</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00530307</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>255 MG (127 MG/M2) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>350 MG (175 MG/M2) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIDOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>400 MG (4.82 MG/KG) EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3.4 G EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE183511AUG04</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE172222SEP04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US01239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.841</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CLEANING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPEDIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK,UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>Q21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>Q21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710NLD00049</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB RALTEGRAVIR POTASSIUM UNK</medicinalproduct>
        <drugauthorizationnumb>22145</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR (+) RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (+) TENOFOVIR DISO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0711FRA00014</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>25 MICROGM/KG IV, 0.15 MICROGM/KG/MIN IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>25 MICROGM/KG IV, 0.15 MICROGM/KG/MIN IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007333374</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-527575</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DOSING REGIMEN REPORTED AS 2500MG AM AND 2000G MS DOSAGE FORM REPORTED AS 2500MG/M2.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: 5MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: 100MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>REPORTED AS 250.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-528430</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-508811</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>
      <patientweight>73.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN TWICE DAILY IN 3-WEEK CYCLES CONSISTING OF 2 WEEKS THERAPY FOLLOWED BY 1 WEEK WITHOUT THERAPY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM REPORTED AS INJECTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM REPORTED AS INJECTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-529005</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>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25792</companynumb>
    <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>H12007</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422703-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</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>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPHOSPHAT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOTRIOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0367245-00</companynumb>
    <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>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTENDRYL G</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0370364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRYZOLINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415296-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POOR QUALITY SLEEP</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415442-00</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378098-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377141-00</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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377588-00</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0416728-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRRUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE W/CLIDINIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334019</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugdosagetext>50 MG QD (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG QD (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG QD (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE (TICLOPIDINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>100 MG QD (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENACE (HALOPERIDOL)</medicinalproduct>
        <drugdosagetext>.75 MG QD (0.75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAMALIL (TIAPRIDE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>25 MG TID (25 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON (IRSOGLADINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007AU03645</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINELL CHEWING GUM FRUIT (NCH)(NICOTINE) CHEWABLE GUM</medicinalproduct>
        <drugauthorizationnumb>77656</drugauthorizationnumb>
        <drugdosagetext>CHEWED</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ROCHE-528723</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0421568-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-06P-163-0339663-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377715-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVELLA-14</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0377681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-506522</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>51</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415405-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0415611-00</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>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>489532E87</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417097-00</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BAYER-200716294GDS</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLEAR CELL CARCINOMA OF THE KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CLEAR CELL CARCINOMA OF THE KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418022-00</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>TWO TABS BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417163-00</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418806-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0417372-00</companynumb>
    <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>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0418993-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULOSQUAMOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420137-00</companynumb>
    <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET COUNT INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420823-00</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378743-00</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421109-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420973-00</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420933-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421150-00</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 TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEGY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421721-00</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421719-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513077-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513078-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422249-00</companynumb>
    <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>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513079-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422619-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513080-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422166-00</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>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0422621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2007JP03214</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURSENNID (NCH)(SENNA GLYCOSIDES (CA SALTS OF PURIFIED SENNA EXTRACT))</medicinalproduct>
        <drugdosagetext>3 TABLETS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOSCOPY LARGE BOWEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0416551-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513084-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0416425-00</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0419611-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513086-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0419208-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0421112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEGY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10/40</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEGY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0378846-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513092-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071000904</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 FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513093-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070901127</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513094-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-L-20070002</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugdosagetext>0 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>0 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513095-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEPFP-L-20070001</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513096-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001227</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008437</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>07H17G37</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>07H31G38</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PD4</medicinalproduct>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01779</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>64108</drugauthorizationnumb>
        <drugindication>SKIN GRAFT</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugindication>SKIN GRAFT</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513100-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006757</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040603158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6MP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071003506</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GDP-07403110</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METVIXIA</medicinalproduct>
        <drugauthorizationnumb>21415</drugauthorizationnumb>
        <drugdosagetext>1 DF TOTAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN LESION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE392422JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020603</drugenddate>
        <drugtreatmentduration>2531</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE328422JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H00978407</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>5 GRAMS DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IOPAMIRON</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2003_0006331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513109-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MESA-2007-036</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALOFALK? (5-AMINOSALICYLIC ACID, 5-ASA)</medicinalproduct>
        <drugauthorizationnumb>21252</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513110-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P640262</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WITHDRAWAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513111-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100942</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>1X 100UG/HR PLUS 1X 50UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>5 TABLETS THREE TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071102672</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>URSO-2007-183</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSO? TABLETS (URSODEOXYCHOLIC ACID)</medicinalproduct>
        <drugauthorizationnumb>20675</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEZATOL SR (BEZAFIBRATE) SINCE ABOUT JULY 2007</medicinalproduct>
        <drugdosagetext>400 MG PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>500 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC (PLAUNOTOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163359ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>75752</drugauthorizationnumb>
        <drugdosagetext>(5 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-481348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>400 MG/M^2.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250 MG/M^2.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>130 MG/M^2.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>EVERY 4-6 HOURS PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-529076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEPRAZINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-529375</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLAPOUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAXIGRIP</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS INJECTION FOR SOLUTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOSPIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NETROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG: PENFLURIDOL.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>ADMINISTERED Q WEEK.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>200 / 300 MG DAILY. APPROXIMATE DURATION OF USE: 2 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>APPROXIMATE DURATION OF USE: TWO AND A HALF YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>APPROXIMATE DURATION OF USE: FOUR AND THREE QUARTER YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>APPROXIMATE DURATION OF USE: 4 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>APPROXIMATE DURATION OF USE: 4 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>APPROXIMATE DURATION OF USE: TWO AND A HALF YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>ADMINISTERED AT BEDTIME. APPROXIMATE DURATION OF USE: 3 MONTHS.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM A-D CREAMY MINT</medicinalproduct>
        <drugbatchnumb>XLFT</drugbatchnumb>
        <drugauthorizationnumb>19487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM A-D CREAMY MINT</medicinalproduct>
        <drugbatchnumb>XLFT</drugbatchnumb>
        <drugauthorizationnumb>019487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070206280</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070800256</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>120.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>1300 MG DAILY FOR 3 DAYS, THEN DECREASED TO 650 MG FOR 3 DAYS ON TWO SEPARATE OCCASIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPRAL</medicinalproduct>
        <drugdosagetext>^7 MONTHS^</drugdosagetext>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071100432</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BODY TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071002024</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CORTISOL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20071000351</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUILONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROZEPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071101841</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071100554</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>66.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMACET</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYTOL HERBAL UNWIND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163224ISR</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOLLICULAR THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugauthorizationnumb>77356</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-TUR-05766-02</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</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>CONGENITAL ARTERIAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS CENTRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROGNATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugdosagetext>400 MG BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13922786</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13971551</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13955877</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOLEBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13950712</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>772MG LOADING DOSE 1 DAY ONCE GIVEN IV ON 27FEB07.ON 06MAR07-09OCT07 482.5 MG 1 IN 1 W (217 DAYS).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>217</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13971502</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>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEMPRA</medicinalproduct>
        <drugdosagetext>20MG/M2 ON DAY 1,8,15. CYC 28DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13572797</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13968573</companynumb>
    <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>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05814-01</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-AUS-05208-01</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG  QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-NLD-05291-01</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ANTIDEPRESSANT DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA AT REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>30 MG QD;</drugdosagetext>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>175 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>150 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>125 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>200 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13316369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13505532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13530654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13544507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13546726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13547518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513147-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13553953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513148-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13560826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPIATES NEGATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513149-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13564869</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13604913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13613492</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>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugbatchnumb>ETH410A</drugbatchnumb>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513152-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13626064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13627542</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13637590</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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13642046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061218</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13662572</companynumb>
    <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513157-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13671136</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOUTHWASH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13671862</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>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513159-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13675434</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13691696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13700984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13712401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13721071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13737747</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513165-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-CAN-05390-01</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATONIC SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROP ATTACKS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG; QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>30 MG QD;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>500 MG QD</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>700 MG QD</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>400 MG QD;</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>700 MG QD;</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>400 MG QD;</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>600 MG;</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>3 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513166-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13766399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513167-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13784517</companynumb>
    <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513168-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13786553</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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13788872</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>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13807698</companynumb>
    <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 FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13808522</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13811153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13814561</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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13817390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13832142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13853197</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13855721</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>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13859004</companynumb>
    <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>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13864657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13881933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
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        <drugenddate>20070725</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13884515</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
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        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13885397</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>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13891353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13892864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13893995</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13532171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13546387</companynumb>
    <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13577994</companynumb>
    <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 FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugbatchnumb>6G10973A</drugbatchnumb>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13579743</companynumb>
    <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13616164</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>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13660584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13788872</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>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13881925</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>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BD-ABBOTT-07P-012-0423253-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028872</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>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUSTER HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>960 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYFAST CONCENTRATE 20 MG/ML</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MCG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AD000105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugauthorizationnumb>50405</drugauthorizationnumb>
        <drugdosagetext>50 MG;TID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-BENELDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42046</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>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>75812</drugauthorizationnumb>
        <drugdosagetext>1700MG/EVERY 22 DAYS/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REFER TO MEDWATCH #2007036816 (16OCT2007) FOR DETAILS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-522240</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>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>TAKEN AS THREE 200 MG TABLETS IN A.M. AND THREE 200 MG TABLETS IN P.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-249569</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.25 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-528439</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</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>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPODONTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042219</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>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHR-JP-2007-040958</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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCOPE 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>3 ML/SEC, BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041183</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>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-SHR-RU-2007-026331</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-034748</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>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>20 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 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>AMBIEN</medicinalproduct>
        <drugdosagetext>1 TAB(S), AS REQ'D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>M85662</drugbatchnumb>
        <drugdosagetext>1000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513207-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-528096</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 3-0-4 TBL. TWICE DAILY FOR 14 DAYS AS PER PROTOCOL. REPORTED AS SECOND CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-014641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
        <drugtreatmentduration>1807</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-041224</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041496</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-025366</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>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3846A</drugbatchnumb>
        <drugdosagetext>10 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3846A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3846A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.25 MG, 3X/DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007SE05994</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34722</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENZEN 8 MG</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMIGOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25818</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26622</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02236</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>146</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>E2756</drugbatchnumb>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>885</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01557</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21163</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-L-20070003</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugdosagetext>30 MG QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1300 MG QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-220863</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>409 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>51 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugdosagetext>1 UNK, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE186711AUG04</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE152601JUN04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO/PREMPHASE</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-KINGPHARMUSA00001-K200701406</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>86299;86461</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>.3 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200709315</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>FEBRILE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLCOSERYL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHOLIN H</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>1255</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711692</companynumb>
    <primarysource>
      <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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2007AC02156</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERONEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>FACTOR V LEIDEN MUTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006090</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513226-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>056-21880-07101420</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>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID B9</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07090215</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07060825</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>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW CARDIAC OUTPUT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 OR 25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUNERPAN (MELPERONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORADORM (MORADORM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM (TORASEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL (DUOVENT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11137</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-10454</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERCOSTAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN 500 MG FILM-COATED TABLETS</medicinalproduct>
        <drugauthorizationnumb>75747</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2007US-11176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>065062</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2006RR-04123</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076165</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060812</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513234-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-SANOFI-SYNTHELABO-F01200700620</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>200MG/25MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>810</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
        <drugtreatmentduration>806</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>810</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-SYNTHELABO-A01200712425</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>D6C451</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-C5013-07051527</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>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE DAILY ON DAYS, 1-28, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513237-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-TUR-05720-02</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL GREAT VESSEL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>128-20785-07100559</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENGUE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 4 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, 4 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200708006662</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 CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>200 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003618</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>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>500</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513241-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ELI_LILLY_AND_COMPANY-NO200709006339</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>N.A.</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ELI_LILLY_AND_COMPANY-RU200711002019</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000536</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>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KE-ELI_LILLY_AND_COMPANY-KE200706005130</companynumb>
    <primarysource>
      <reportercountry>KENYA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>25 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOHIMBINE</medicinalproduct>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711000691</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </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>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A291213</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, 2/D</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR200710007285</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200710004237</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710007469</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>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>140 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>217</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugdosagetext>40 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711001147</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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000712</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>600 UG, EVERY 3 HRS</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>600 UG, 3/D</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>125 UG, OTHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCTALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>12.5 UG, OTHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 UG, OTHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>75 UG, OTHER</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710007465</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugdosagetext>18 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711000027</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 IU, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>22 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>32 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709004643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>26.303</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A282238</drugbatchnumb>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.5 MG, 2/D</drugdosagetext>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX200710003399</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002152</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42070</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>75812</drugauthorizationnumb>
        <drugdosagetext>2020MG</drugdosagetext>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-07P-150-0423256-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERCEPTED MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>2197-44-1048930</drugbatchnumb>
        <drugauthorizationnumb>76495</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>39526-3</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>400 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USBAX-L-20070032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2 1 X WK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>2 MG/KG 1 X WK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>4 MG/KG ONCE</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513265-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW26138</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>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE267120JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-H01059007</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
        <drugtreatmentduration>970</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>1143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>180/12.5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>1143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE336622JUL04</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-WYE-G00558907</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugdosagetext>1000 IU EVERY 1 TOT</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE263720JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.01</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
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    <companynumb>070130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALFLYTELY</medicinalproduct>
        <drugauthorizationnumb>21551</drugauthorizationnumb>
        <drugdosagetext>20 MG/2 L, 1X, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071004491</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>6H08245G</drugbatchnumb>
        <drugdosagetext>1TABL, Q.D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250770</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>RECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>RECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>RECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYCARBOPHIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS BIFIDUS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007072310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>NICOTINE DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAGLIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513275-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GENENTECH-250652</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093033</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513277-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007083971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugbatchnumb>20757</drugbatchnumb>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>11185</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US17818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugauthorizationnumb>85966</drugauthorizationnumb>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLINTANE(PROLINTANE)</medicinalproduct>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006082</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.01</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR; 15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513280-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006081</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>BELGIUM</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-250587</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006061714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-GENENTECH-250396</companynumb>
    <primarysource>
      <reportercountry>LEBANON</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092806</companynumb>
    <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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092773</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>68.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006087</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006086</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006085</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI010157</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021386</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>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F01200601426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV BOLUS AND 2400 MG/M2 IV CONTINUOUS INFUSION FOR 46 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID FUNCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092554</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.545</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</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</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>FREQ:AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017411</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200710AGG00738</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIROFIBAN HYDROCHLORIDE (TIROFIBAN HCL) (7.5 ML, 14 ML)</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>(7.5 MG TOTAL INTRAVENOUS BOLUS), (INTRAVENOUS DRIP)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIROFIBAN HYDROCHLORIDE (TIROFIBAN HCL) (7.5 ML, 14 ML)</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>(7.5 MG TOTAL INTRAVENOUS BOLUS), (INTRAVENOUS DRIP)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016418</companynumb>
    <primarysource>
      <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006116</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>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (FUROSEMIDEE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022209</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513308-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-13930169</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092144</companynumb>
    <primarysource>
      <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>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513310-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>79.545</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
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        <drugenddate>20071027</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>5513311-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-PFIZER INC-2007092941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
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        <drugstartdate>20070101</drugstartdate>
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        <drugenddate>20070101</drugenddate>
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    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20071108</receivedate>
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    <companynumb>2007BI022861</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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      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32027</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513313-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023399</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>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023402</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32022</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513315-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023414</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>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513316-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023457</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI015865</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>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI02646</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>101.6057</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092496</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>TEXT:1 DROPPERFUL ONCE A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugdosagetext>FREQ:WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI012217</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423438-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE/ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423472-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN-TANNIN COMPLEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED AMLODIPINE</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713462BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVITAMINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WATER POLLUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 880 MG  UNIT DOSE: 220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>VACTERL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007092308</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092372</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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023052</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023092</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>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023223</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>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023230</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>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513332-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023348</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023358</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007092378</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARALGIN FORTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513335-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007092404</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>TEXT:35 MG, ONCE WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFMETAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007092777</companynumb>
    <primarysource>
      <qualification>3</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007092210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</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>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007072315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023354</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>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <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>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CTI_00926_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.0802</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYFLO</medicinalproduct>
        <drugbatchnumb>3044378</drugbatchnumb>
        <drugauthorizationnumb>20471</drugauthorizationnumb>
        <drugdosagetext>600 MG QID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MASTOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROCROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163444USA</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74656</drugauthorizationnumb>
        <drugindication>THYMOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007090328</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIS CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007041090</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:80MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:160MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>TEXT:1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513344-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>TEXT:10MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513346-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007092036</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>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163520USA</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>40333</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS (1800 MG/M2), INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>400 MG/M2, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>WEEKLY 200 MG/M2, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>WEEKLY 5 MG/KG</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313409-00</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>86.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75857</drugauthorizationnumb>
        <drugdosagetext>2-8 ML, HOURLY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN (TIMENTIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN-INSULIN (INSULIN NOVOLIN 70/30)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>0.45 NS WITH 30 KCL (SODIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15430</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIPENT</medicinalproduct>
        <drugauthorizationnumb>20122</drugauthorizationnumb>
        <drugdosagetext>4 MG Q3W IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1 MG Q3W IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313395-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>71850</drugauthorizationnumb>
        <drugdosagetext>2 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEP-701</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-163-0313388-00</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXMEDETOMIDINE INJECTION (DEXMEDETOMIDINE HYDROCHLORIDE INJECTION) (D</medicinalproduct>
        <drugauthorizationnumb>21038</drugauthorizationnumb>
        <drugdosagetext>8 - 14 ML PER HR, CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE/SALMETERO (FLUTICASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL / IPRATROPIUM (SALBUTAMOL W / IPRATROPIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE 0.12% (CHLORHEXIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONDAPARINUX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D5 1/2 NS (DEXTROSE AND SODIUM CHLORIDE INJECTION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL (BISACODYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0378826-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>31.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0372776-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMEMAZINE TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPATEPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423132-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019892</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423243-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</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>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXIINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088852</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:2GRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZANIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007032047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEQUAL LIMB LENGTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006110644</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFON FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513360-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2006113873</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006113159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513362-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022756</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>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32016</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513363-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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        <drugstartdate>20070124</drugstartdate>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
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    <patient>
      <patientonsetage>10</patientonsetage>
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      <reaction>
        <reactionmeddrapt>ADENOVIRUS INFECTION</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
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        <drugstartdate>20061009</drugstartdate>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
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        <drugstartdate>20061213</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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        <drugstartdate>20070117</drugstartdate>
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    <transmissiondateformat>102</transmissiondateformat>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receiptdate>20071029</receiptdate>
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      <reportercountry>SPAIN</reportercountry>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
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  <safetyreport>
    <safetyreportid>5513367-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
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    <companynumb>FR-PFIZER INC-2006044957</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>
      <patientweight>62.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513368-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
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    <companynumb>US-PFIZER INC-2007093700</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>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513369-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007087220</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHROMELALGIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISTIN</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20061108</drugstartdate>
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        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
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    <safetyreportid>5513370-8</safetyreportid>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NEGATIVISM</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>20071025</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
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        <drugindication>MYCOPLASMA INFECTION</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
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        <medicinalproduct>CLOBAZAM</medicinalproduct>
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        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
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        <medicinalproduct>MUCODYNE</medicinalproduct>
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        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
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        <medicinalproduct>ASVERIN</medicinalproduct>
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        <medicinalproduct>HOKUNALIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
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    <safetyreportid>5513371-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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513374-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006042</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN INFANT DEATH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513375-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006050</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513376-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006048</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513377-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007034318</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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513378-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006047</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </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>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092427</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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513381-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092494</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2006119892</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061025</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
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    <safetyreportid>5513384-8</safetyreportid>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513385-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006053</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG; INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG; INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG; INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG; INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513386-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006052</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6.08</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513387-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513388-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006141387</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLULISINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513389-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006129290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERA-HS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007057856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007036997</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006051</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006069</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>1.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007046344</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
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        <medicinalproduct>HEPARIN CALCIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
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      <drug>
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        <medicinalproduct>FOSFOMYCIN SODIUM</medicinalproduct>
      </drug>
      <drug>
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        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070429</drugstartdate>
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        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513395-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2007092737</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>5</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TABLETS</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
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    </patient>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007041857</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>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:5MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:25MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513397-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007075823</companynumb>
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      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE LAMIVUDINE AND ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513398-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080004</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>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513399-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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    <companynumb>MEDI-0006058</companynumb>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
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    <safetyreportid>5513400-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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        <drugstartdate>20061026</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
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        <drugstartdate>20061222</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
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        <drugstartdate>20070118</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
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    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
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      <patientsex>1</patientsex>
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        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <reportercountry>BELGIUM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
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      <drug>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
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      <drug>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
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        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
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  <safetyreport>
    <safetyreportid>5513404-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
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    <companynumb>US-PFIZER INC-2007074905</companynumb>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
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        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
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      <drug>
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        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-ABBOTT-07P-167-0423436-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
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      <drug>
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        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068903</companynumb>
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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>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugbatchnumb>15407</drugbatchnumb>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
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  <safetyreport>
    <safetyreportid>5513407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
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    <companynumb>CO-PFIZER INC-2007073269</companynumb>
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      <reportercountry>COLOMBIA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
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    <safetyreportid>5513408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
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    <receiver></receiver>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
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        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
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    <safetyreportid>5513409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <drug>
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      <drug>
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      <drug>
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      <drug>
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    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513414-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007065483</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>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007086551</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </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>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007086276</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007084464</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugindication>ASPERGILLOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>TEXT:1 DF; 1DF-FREQ:FREQUENCY: DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTALLINE</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>009986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>009986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>009986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT</medicinalproduct>
        <drugdosagetext>FREQ:ONE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugdosagetext>TEXT:1-2 PILLS-FREQ:DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>FREQ:NIGHTLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugdosagetext>FREQ:PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
        <drugdosagetext>FREQ:PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513419-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007083187</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513420-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-PFIZER INC-2007083151</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugauthorizationnumb>019268</drugauthorizationnumb>
        <drugindication>INDUCED LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513421-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007082583</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENOGASTRIC REFLUX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID HORMONES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513422-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007082770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513423-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007082326</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PASIL</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PASIL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugdosagetext>TEXT:2 DOSE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.5GRAM-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPA</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007081430</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-0518</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513425-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-PFIZER INC-2007081580</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>HEPATITIS A</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0422869-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20060319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513427-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-ABBOTT-07P-167-0423431-00</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513428-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423376-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL GASTRIC ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 18</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513429-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423223-00</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>GLYCOSYLATED HAEMOGLOBIN INCREASED</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>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>40 MG, 2 IN ONE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2 IN ONE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugdosagetext>30 MG ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513430-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WAIST CIRCUMFERENCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513431-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079149</companynumb>
    <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 UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513432-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513433-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007078940</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLOMYCIN</medicinalproduct>
        <drugdosagetext>TEXT:2 DF</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513434-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007087554</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513435-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0005286</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0005265</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006019</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006017</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007086993</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007091686</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERY DAY TDD:900MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL - SLOW RELEASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMBYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007085412</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>TEXT:5MG/40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT</medicinalproduct>
        <drugdosagetext>TEXT:300MG/12.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMOL</medicinalproduct>
        <drugdosagetext>TEXT:2 PUFFS-FREQ:PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>22128</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE890111SEP06</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>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060906</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE/SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG EVERY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G IF NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG EVERY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060906</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007090154</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPES VIRUS 6 SEROLOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PALPABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006016</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513447-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006015</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513448-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006025</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006024</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </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>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006021</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOVIRAL UPPER RESPIRATORY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007092061</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugindication>PITUITARY TUMOUR BENIGN</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092025</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250824</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q6W</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX PRODUCT NOS</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513455-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513456-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513457-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006020</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOVIRAL UPPER RESPIRATORY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513458-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006036</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513459-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006032</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006031</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006030</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006041</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0006039</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>15 MG/KG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250824</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q6W</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX PRODUCT NOS</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007091902</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXASCAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513467-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK235052</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOLOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIBLASTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513468-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007091857</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513469-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0423802-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <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>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-07P-066-0360226-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
    </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>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugindication>RETROVIRAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RETROVIRAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>200/245 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugdosagetext>750 MG/5 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK251276</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007092083</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>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092855</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245538</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>GUILLAIN-BARRE SYNDROME</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>20060217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007092990</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-UK250775</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>MIMPARA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008812</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092985</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GENENTECH-251068</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK250995</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094177</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-250845</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093601</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093603</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093570</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007093584</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093520</companynumb>
    <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 FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093385</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093352</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007093302</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>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN/PRAVASTATINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE/PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093276</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:100MG-FREQ:DAILY</drugdosagetext>
        <drugindication>FAMILY STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093176</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>GASTRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00401507</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMOPAX MONO</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093234</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007093156</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>010392</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DAILY DOSE:15MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513502-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.259</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>18142/18656</drugbatchnumb>
        <drugdosagetext>735 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>156374</drugbatchnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGARTE</medicinalproduct>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007093130</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>50 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750 MG/M2, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1.4 MG/M2, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, QDX5D/21DC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513506-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004637</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70707</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513507-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>50 MG/KG, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750 MG/M2, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1.4 MG/M2, Q21D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MG, QDX5D/21DC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423473-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513509-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-GENENTECH-250365</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, 1/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513510-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004445</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DIAPHRAGM DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>74514</drugauthorizationnumb>
        <drugdosagetext>50 MG; TID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERINEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03596</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513512-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03597</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>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG, INTRAVENOUS; 2.20 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG, INTRAVENOUS; 2.20 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE(MAGNESIUM OXIDE)</medicinalproduct>
        <drugdosagetext>1980.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACIN (ISEPAMICIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03615</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03633</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>-1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513515-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.249</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03656</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000499</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG; QD; PO, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG; QD; PO, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG; QD; PO, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG; QD; PO, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP011195</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>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE 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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOMATOSIS CEREBRI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020998</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP007552</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>320 MG;</drugdosagetext>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513521-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006SP008987</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG;QD;PO, 400 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG;QD;PO, 400 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ACO_00397_2007</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>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIRDALUD (SIRDALUD - TIZANIDINE HYDROCHLORIDE) (NOT SPECIFIED)</medicinalproduct>
        <drugauthorizationnumb>20397</drugauthorizationnumb>
        <drugdosagetext>6 MG QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010500</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>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOTEN (ATENOLOL) (50 MG)</medicinalproduct>
        <drugauthorizationnumb>73457</drugauthorizationnumb>
        <drugdosagetext>50 MG, TWICE A DAY; ORAL, 50 MG, DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOTEN (ATENOLOL) (50 MG)</medicinalproduct>
        <drugauthorizationnumb>73457</drugauthorizationnumb>
        <drugdosagetext>50 MG, TWICE A DAY; ORAL, 50 MG, DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPA-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513524-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423308-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</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>20051021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC W/MISOPROSTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513525-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423219-00</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>69.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERRAPEPTASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513526-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513527-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011029</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>75876</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON /00480201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513528-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011034</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>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76671</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILEST (CILEST)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513529-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513530-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-247862</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021096</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>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>QD;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0604S-0092</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0604S-0098</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REMOVAL OF RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>34 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPLICATIONS OF TRANSPLANTED KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-247864</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GENENTECH-247865</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513536-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-247914</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513537-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-NO-0604S-0094</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>500 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04905</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ENDOMETRIAL CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugauthorizationnumb>20489</drugauthorizationnumb>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE IN OIL INJ</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRONE</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRIOL (ESTRIOL)</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DHEA(PRASTERONE)</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04912</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>GALLBLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>80354</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0005516</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0005351</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL SHIFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>120 MG, INTRAMUSCULAR; 120 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>120 MG, INTRAMUSCULAR; 120 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICLAV (AMOXICILLIN, CLAVULANIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC-MUPS (AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, OMEPRAZOLE MAGNESI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0704USA01595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>790</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYL PIPERIDINOACETYLAMINOBENZOATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513543-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA00304</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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00052</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0710BEL00011</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00030</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247994</companynumb>
    <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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.8 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.2 ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER TABLETS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30114_2007</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPSOCLONUS MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230208K07BRA</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>190010L07JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADTROPIN</medicinalproduct>
        <drugauthorizationnumb>17067</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230038K07AUS</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>POMP-11257</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugdosagetext>20 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 ML, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-248073</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1 G, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6 TABLET, 1/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS</medicinalproduct>
        <drugdosagetext>10-15 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>310002L07JPN</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLLITROPIN ALPHA (FOLLITROPIN ALFA)</medicinalproduct>
        <drugauthorizationnumb>20378</drugauthorizationnumb>
        <drugdosagetext>1125 IU</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
        <drugdosagetext>1950 IU</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADTROPIN</medicinalproduct>
        <drugdosagetext>1000 IU</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004629</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70707</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513557-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004630</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70707</drugauthorizationnumb>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>POISONING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-248093</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513559-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENENTECH-248097</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>BREAST CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-248149</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIVOBET</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 UNK, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>4 UNK, UNK</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>137.5 UNK, QD</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugdosagetext>60 UNK, QD</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 UNK, QD</drugdosagetext>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-248167</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.3 ML, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513562-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-248172</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>60 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-248173</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.68 ML, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513564-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-248235</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GENENTECH-248258</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>101</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513566-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL ANESTHESIA (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248279</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL ANESTHESIA (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248280</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL ANALGESIC</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-248371</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>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513570-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-248448</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JO-GENENTECH-249113</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>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.1 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513572-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-242226</companynumb>
    <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>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1.25 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENENTECH-249916</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>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513574-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US000608</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>4 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>6 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>6 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM (TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCLCLOVIR (GANCICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM (ESOMPERAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS (FOLIC ACID, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THORAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE2007-0029</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYSTAL URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPECIFIC GRAVITY URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>77859</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED LOW-DOSE ANGIOTENSIN-CONVERTING ENZYME INHIBITOR: LONG TER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ADE2007-0030</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>77859</drugauthorizationnumb>
        <drugdosagetext>750MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED LOW-DOSE ANGIOTENSIN-CONVERTING ENZYME INHIBITOR: INITIATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513577-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24192RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>089049</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513578-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21905BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513579-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22905BP</companynumb>
    <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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513580-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23066BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513581-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22907BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23374BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESIDUAL URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513583-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23376BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24042BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>704894A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513585-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22948NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</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>20050406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24172BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513587-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22925BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-02489BP</companynumb>
    <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVA CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
        <drugdosagetext>0.1 %</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT AQUA NASAL SPRAY</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFUDEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETNUS SHOT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOL 3</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04903</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>ENDOMETRIAL CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugauthorizationnumb>20489</drugauthorizationnumb>
        <drugdosagetext>0.188 MG, QAM, + 0.375MG QPM, 2.25 MG DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugauthorizationnumb>20489</drugauthorizationnumb>
        <drugdosagetext>0.188 MG, QAM, + 0.375MG QPM, 2.25 MG DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE IN OIL INJ</medicinalproduct>
        <drugdosagetext>37.5 MG QAM + 75MG QPM TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE IN OIL INJ</medicinalproduct>
        <drugdosagetext>37.5 MG QAM + 75MG QPM TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>0.875 MG, DAILY, 0.375 MG, QAM + 0.75 MG QPM</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>0.875 MG, DAILY, 0.375 MG, QAM + 0.75 MG QPM</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DHEA(PRASTERONE) 5MG</medicinalproduct>
        <drugdosagetext>0.625 MG, QAM + 1.25MG QPM, 2.5 MG, DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DHEA(PRASTERONE) 5MG</medicinalproduct>
        <drugdosagetext>0.625 MG, QAM + 1.25MG QPM, 2.5 MG, DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRONE</medicinalproduct>
        <drugdosagetext>0.375 MG, QAM + 0.75MG QPM</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRIOL(ESTRIOL)</medicinalproduct>
        <drugdosagetext>0.375 MG, QAM + 0.75MG QPM</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513590-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19736BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513591-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19849BP</companynumb>
    <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513592-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19237BP</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>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</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>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugindication>ORAL HERPES</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513593-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BP-20038BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513594-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21973BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513595-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22906BP</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>DYSURIA</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRELSTAR</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513596-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18408PF</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513597-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23996BP</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513598-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24043BP</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>BRONCHITIS</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>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513599-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-AP-00113AP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR + RITONAVIR CO-ADMIN</medicinalproduct>
        <drugdosagetext>TIPRANAVIR/NORVIR: STRENGTH 250MG/100MG; DAILY DOSE: 1000MG/400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISEPTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESSENTIALE FORTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513600-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-UK-00068UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRUNTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METHYLMALONIC ACIDURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RETROVIRAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugauthorizationnumb>076844</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513601-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23916MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SECOTEX CAPSULES 0.4MG</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513602-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22902BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513603-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22901BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513604-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22900BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513605-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22898BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513606-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22911BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513607-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23984BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703709A,7C2218</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513608-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06608GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17922NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICLONADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513610-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17628NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513611-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06133GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513612-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06636GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513613-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-SW-00415SF</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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS TAB 80 MG</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS TAB 80 MG</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINATIL COMP</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513614-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06635GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513615-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06634GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513616-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06633GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513617-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06637GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL MALROTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugauthorizationnumb>063277</drugauthorizationnumb>
        <drugindication>INTESTINAL MALROTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24084NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513619-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23314BP</companynumb>
    <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>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17704NB</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>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EC-DOPARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24200BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22908BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513623-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23599AU</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513624-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22913BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22912BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23699BP</companynumb>
    <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>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21901NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIKORANMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO SLOW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2006-BP-14004NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KANAMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23657BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-19915BP</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>765014A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513631-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23661BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23505SG</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM RESPIMAT</medicinalproduct>
        <drugauthorizationnumb>65127</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORACORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERIPHYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513633-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22910BP</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513634-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06613GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513635-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06610GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513636-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06609GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06615GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513638-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06616GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
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        <drugenddate>20040322</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
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      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER STAGE I</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
        <drugauthorizationnumb>20489</drugauthorizationnumb>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HYPOGONADISM MALE</drugindication>
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        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTERONE IN OIL INJ</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DHEA(PRASTERONE)</medicinalproduct>
        <drugdosagetext>TROCHE</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06617GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COLON CANCER STAGE III</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON</medicinalproduct>
        <drugindication>FLATULENCE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5513641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051104</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06599GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513643-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06600GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
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        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>20030813</drugstartdate>
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  <safetyreport>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <patientonsetage>70</patientonsetage>
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        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
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        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
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        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
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        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
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    <patient>
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        <drugcharacterization>1</drugcharacterization>
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    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06625GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513650-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06626GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06627GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06629GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06632GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM-BROMIDE</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030912</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513654-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17487BP</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
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        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23366BP</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23363BP</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5513657-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23362BP</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23361BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>5513659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23232BP</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23236BP</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>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>5513661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20791BP</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>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5513662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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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>
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        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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        <drugauthorizationnumb>020579</drugauthorizationnumb>
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        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
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  <safetyreport>
    <safetyreportid>5513663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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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>BRADYCARDIA</reactionmeddrapt>
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      <drug>
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      <drug>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21872</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513665-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23669BP</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC COOL MINT (TABLETS)</medicinalproduct>
        <drugbatchnumb>A28337</drugbatchnumb>
        <drugauthorizationnumb>21698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22909BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23456BP</companynumb>
    <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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002582</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>1 MG/KG, UID/QD, IV DRIP, 5 MG/KG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>1 MG/KG, UID/QD, IV DRIP, 5 MG/KG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MENINGITIS CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROCYTOSINE (FLUCYTOSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002143</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CORYNEBACTERIUM SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>250 MG, UID/QD, IV NOS, 150 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>250 MG, UID/QD, IV NOS, 150 MG, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 G, UID/QD, IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugdosagetext>400 MG, UID/QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-227742</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>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002093</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDULLOBLASTOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/KG, UID/QD, IV NOS, 5 MG/KG, UID/QD, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>2.5 MG/KG, UID/QD, IV NOS, 5 MG/KG, UID/QD, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEMENMIC (MINERALS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUTIONS FOR PARENTERAL NUTRITION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC (AMEZINIUM METILSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN (LENOGRASTIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C (GLYCYRRHIZIC ACID, AMMONIUM SALT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513672-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-232661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.131</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL #3 (UNITED STATES)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513673-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-232711</companynumb>
    <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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q4W</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugdosagetext>2/240</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513674-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002585</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513675-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002001576-FJ</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AV DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYMOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLAPREZINC (POLAPREZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFIDOBACTERIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004970</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>HAEMORRHAGIC OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004936</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004132</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE (CLOTIAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007EU001497</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>06J11/17-CC-480</drugbatchnumb>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRPFM-S-20040137</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20070045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugauthorizationnumb>20388</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000236</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>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext> ;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ACO_00399_2007</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIRDALUD (SIRDALUD RETARD - TIZANIDINE HYDROCHLORIDE) 6 MG (NOT SPECIF</medicinalproduct>
        <drugauthorizationnumb>21447</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOLVEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL MITE W/POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALA_00027_2007</companynumb>
    <primarysource>
      <reportercountry>TURKEY</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</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>BLOOD URIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TURGOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugauthorizationnumb>19618</drugauthorizationnumb>
        <drugdosagetext>(500 MG TID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018328</companynumb>
    <primarysource>
      <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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020045</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIVOBET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30816_2007</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>S5648</drugbatchnumb>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>(20 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>(20 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01782_2007</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRODUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071112</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2007-0013779</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>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513690-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-269155</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>60 IU, BID</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268972</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>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>12 IU, QD</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITIGLINIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-269150</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-269047</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 GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513694-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268798</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>23 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN U CHU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268544</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>32 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513696-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268684</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-NOVOPROD-266925</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>14 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>10/25/200</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURESIS COMP</medicinalproduct>
        <drugdosagetext>1 X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMOX</medicinalproduct>
        <drugdosagetext>2 + 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, 1X1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>0,5 + 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 X 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFORMIN</medicinalproduct>
        <drugdosagetext>2 X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-269027</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>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>2-30</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513699-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268806</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>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>019991</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-269129</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
        <drugdosagetext>90 UG/KG TOTAL: 4.8 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-269151</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASTASE</medicinalproduct>
        <drugdosagetext>90 UG/KG TOTAL: 9.6 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513702-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-268970</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTAPHANE PENFILL</medicinalproduct>
        <drugauthorizationnumb>19959</drugauthorizationnumb>
        <drugdosagetext>250 IU, SINGLE</drugdosagetext>
        <drugindication>DRUG ADMINISTRATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-267706</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MEQ, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268199</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>12-16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>4-8 IU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOLET N CHU</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-268268</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROFEM</medicinalproduct>
        <drugauthorizationnumb>40312</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTIFICIAL MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAX D3                        /00944201/</medicinalproduct>
        <drugdosagetext>2500 MG+880 IU, UNK</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEFOR</medicinalproduct>
        <drugdosagetext>.75 TAB, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-268091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>TP50285</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>40 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-249400</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>24 U, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>10-12</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>9+4+7</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL N CHU</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050715</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050406</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050406</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-NOVOPROD-266236</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD AROUND NECK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>42 IU, QD</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513709-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-268992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>5/160 ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513712-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL ER</medicinalproduct>
        <drugbatchnumb>ML070399</drugbatchnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513714-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugbatchnumb>B95479</drugbatchnumb>
        <drugdosagetext>3000MG IV Q8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>750MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>1-2 SPRAYS EVERY 4 HRS PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>SPAIN</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACITRETIN</medicinalproduct>
        <drugdosagetext>25 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYTHRODERMIC PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071110</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>3 + 3 200MG EACH 3 IN AM 3 IN PM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG 3 TIMES PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513721-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>62.1428</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>100 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513722-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(GENENTECH)</medicinalproduct>
        <drugbatchnumb>N62268</drugbatchnumb>
        <drugdosagetext>10 MG/KG</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB(GENENTECH)</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513723-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>070806-0000741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOPROFEN</medicinalproduct>
        <drugauthorizationnumb>21903</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513724-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP16216</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>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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PANCREATIC CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLITOSE</medicinalproduct>
        <drugdosagetext>3 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513725-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007TW15944</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>800MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513726-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEUROBLASTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0032</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US18486</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>ACID FAST BACILLI INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTERIOR CHAMBER INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT SUBCAPSULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISCLERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCERATIVE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>175 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>3 G/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061101542</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>600 MG, 3 IN 1 DAY, ORAL ; 600 MG, 3 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>600 MG, 3 IN 1 DAY, ORAL ; 600 MG, 3 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>600 MG, 3 IN 1 DAY, ORAL ; 600 MG, 3 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>600 MG, 3 IN 1 DAY, ORAL ; 600 MG, 3 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061102364</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT18670</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/3 TIMES EVERY 1 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061231</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513731-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18752</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORASEQ</medicinalproduct>
        <drugauthorizationnumb>20831</drugauthorizationnumb>
        <drugdosagetext>FORM 12 / BUDE 400 UG, BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSORO</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANESTHETICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513732-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03229</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513733-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US06145</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>72.562</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>57MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTOPREV</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513734-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE18685</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513735-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP12866</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DECALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>GENERAL PHYSICAL HEALTH DETERIORATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AR17826</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLPER B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1.5 MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP13329</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</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>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>235</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061123</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060709</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>3.75 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DE17750</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVIDEL</medicinalproduct>
        <drugauthorizationnumb>17962</drugauthorizationnumb>
        <drugdosagetext>2.5MG , ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513739-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03262</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18429</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 400MG TABLETS, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IE18796</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugauthorizationnumb>018245</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02580</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLAR OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
        <drugtreatmentduration>1197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DK05194</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESERIL</medicinalproduct>
        <drugauthorizationnumb>12516</drugauthorizationnumb>
        <drugdosagetext>6 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050204</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KODIMAGNYL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERALOC - SLOW RELEASE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>0.6 G/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14501</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513745-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02183</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN ACETATE LAR</medicinalproduct>
        <drugauthorizationnumb>21008</drugauthorizationnumb>
        <drugdosagetext>10 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14474</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13322</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>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17876</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARZINOPHILIN</medicinalproduct>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02185</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IN18484</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SCHISTOCYTES PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>225 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>720 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>KIDNEY TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061104635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>245032D</drugbatchnumb>
        <drugdosagetext>220 MG, 1 IN 1 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US18607</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLASTOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BLASTOMYCES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18464</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>3  TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000131</drugstartdate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14556</companynumb>
    <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 FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TW16996</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03183</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>928</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US10513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MCG DAILY</drugdosagetext>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>40 MG, QID</drugdosagetext>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugdosagetext>2 TABS QID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FLUORIDE</medicinalproduct>
        <drugdosagetext>1.1% BRUSH WITH 2X A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
        <drugdosagetext>5-15 ML PRN QD</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500MG 1-2 TABS QID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLICON</medicinalproduct>
        <drugdosagetext>1-2 TABS QID PRN</drugdosagetext>
        <drugindication>FLATULENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CH18637</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugdosagetext>45 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUGERON</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENIL MITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13907</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>
      <patientweight>92.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY CASTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR SHUNT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SERUM FERRITIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US10703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.167</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APICAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>100 MCG/HR, Q72H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
        <drugdosagetext>875 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061000805</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>1600 MG, 1 IN 1 DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1 IN 1 DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01882</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE: 400 MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10291</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG X 11 TIMES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>30 MG X 19 TIMES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060608</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>50 TO 95 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>1009</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>95MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040319</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050317</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>95MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
        <drugtreatmentduration>93600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DK18273</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
        <drugtreatmentduration>303</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE18238</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 3 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513767-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007AT15154</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC ^SOLVAY^</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLADEM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEM ^WARNER-LAMBERT^</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RAYNAUD'S PHENOMENON</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRETAB</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN /UNK/</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTINEM</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL HERPES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060802253</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>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>, 1 IN 1 TOTAL</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALCID (SALSALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN (GLYCERYL TRINITRATE) SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURATUSS (RESPAIRE-SR-120)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL (OTHER DERMATOLOGICAL PREPARATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM TAB SR (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KWELL (LINDANE) SHAMPOO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE (HYOSCYAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANTIL (MEPENZOLATE BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE (LOTRISONE) CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL (KETOCONAZOLE) CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH HUMULIN INSULIN (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR HUMULIN INSULIN (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007PT18608</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>5'NUCLEOTIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-PLATELET ANTIBODY POSITIVE</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>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>50 MG, Q12H</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>960 MG, TIW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03220</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>580</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2 MG, EVERY 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50-100 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007KR18444</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18436</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>018927</drugauthorizationnumb>
        <drugdosagetext>10 ML, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG, Q48H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513774-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17890</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>60 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061000327</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>^FOR MANY YEARS^</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC (ZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION (CARDIAC THERAPY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02058</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG - 225 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.433</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02533</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>90 DF PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMEPRAZINE TAB</medicinalproduct>
        <drugdosagetext>20 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007KR17480</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070402521</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>85055</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070302748</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>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>85055</drugauthorizationnumb>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE392522JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
        <drugtreatmentduration>1870</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE992212APR05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE395222JUL05</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>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02040</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>12-450MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>3097</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, BID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, QD MANE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPRO</medicinalproduct>
        <drugdosagetext>400 MG, QD NOCTE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD NOCTE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18471</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US10513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MCG DAILY</drugdosagetext>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>40 MG, QID</drugdosagetext>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugdosagetext>2 TABS QID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FLUORIDE</medicinalproduct>
        <drugdosagetext>1.1% BRUSH WITH 2X A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
        <drugdosagetext>5-15 ML PRN QD</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500MG 1-2 TABS QID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLICON</medicinalproduct>
        <drugdosagetext>1-2 TABS QID PRN</drugdosagetext>
        <drugindication>FLATULENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP11344</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2592</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17858</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>UP TO 700 MG/DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18603</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGERON</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02439</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALBUMINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>5 DF/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TR18666</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03219</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007US18485</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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTEROIDES INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CALCULUS REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAPAROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIDIVERTICULAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>225 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>4 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03292</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugdosagetext>120MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007DE18487</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugindication>RENAL AND PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>240 MG/24 HRS</drugdosagetext>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ZA18409</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK -THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KESSAR</medicinalproduct>
        <drugindication>MASTECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOPAYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE394222JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE394322JUL05</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031209</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE979012JUL04</companynumb>
    <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>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE226205FEB03</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>ANTIPHOSPHOLIPID ANTIBODIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-03833</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>60.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1000 MG BID WITH NEPHRO SUPPLIMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE       (ISOSORBIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO                  (CALCIUM ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00994207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugauthorizationnumb>018553</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</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>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>22083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04520</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>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>10 TABLETS OF 1000MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>750 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PAR_01704_2007</companynumb>
    <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 EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugauthorizationnumb>21778</drugauthorizationnumb>
        <drugdosagetext>(625 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYCHOTROPIC DRUGS                (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711001088</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>30 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200710006567</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011113</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011028</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200711001942</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200710006166</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COOMBS NEGATIVE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</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>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020128</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERALITHE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020128</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPHASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000638</companynumb>
    <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, 2/D</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL200709001138</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugbatchnumb>A347314</drugbatchnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850 UNK, 3/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTIDINE/BETAHISTIDINE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>16 UNK, 2/D</drugdosagetext>
        <drugindication>MENIERE'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
        <drugdosagetext>38 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>30 UNK, 3/D</drugdosagetext>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513825-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200711001206</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECONIUM ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING ENTEROCOLITIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASE NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BRIEF PSYCHOTIC DISORDER WITH MARKED STRESSORS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060802</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060802</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEPRAZINE TAB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513826-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711001557</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPIXOL</medicinalproduct>
        <drugdosagetext>10 MG, 2/W</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugdosagetext>700 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>200 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200711001653</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>12.5 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040405</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>25 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>62.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>25 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>12.5 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVAL</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513828-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513829-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, EACH MORNING</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200610002435</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.15</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513831-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200704005210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.608</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOXYHAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, EACH EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>25 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, EACH MORNING</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
        <drugdosagetext>30 MG, EACH EVENING</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>1 D/F, 4/D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200708006887</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011204</drugenddate>
        <drugtreatmentduration>141</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>20011204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>2052</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>0.75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011120</drugenddate>
        <drugtreatmentduration>582</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>1.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020604</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>0.75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020730</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>0.375 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>1730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>1 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021119</drugenddate>
        <drugtreatmentduration>946</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>1702</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04658</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>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, 1X/DAYL:QD, ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, 1X/DAYL:QD, ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR                         /00090101/ (ADENOSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG                    /00030501/ (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL                 /00054301/ (CHLORMEZANONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200710615BFR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONUCLEOSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTA</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ETHYLSUCCINATE</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513835-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200711142BNE</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 4 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HUDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 450 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 18 ?G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 800 ?G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 7.50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZACHEW MELTDOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513836-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711218BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714267BWH</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513838-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200715588GDS</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROPHTHALMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 500 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIDATO</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 2 G  UNIT DOSE: 2 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 16000 U  UNIT DOSE: 4000 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 0.25 MG  UNIT DOSE: 0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200711511BWH</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL WITH CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712855BWH</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>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5%</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20070805328</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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 TREATMENTS 2 WEEKS APART</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ON INFLIXIMAB FOR OVER 14 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101601</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071002087</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>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>6 INFUSIONS (INFUSION #2-7) ON UNSPECIFIED DATES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENOPENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070905195</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071002208</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</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>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20071006673</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOJECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513849-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070901704</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</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>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BANAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AT16632</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>URINARY ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01104707</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE393822JUL05</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>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01106407</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>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01104507</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>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007SP003134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML;BID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL W/IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX 23</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugdosagetext>1MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-03706</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-BAXTER-2007BH008614</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0705009</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGADON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513861-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>576 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>38 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>480 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>176 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKING SODA RINSES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>2940 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713567BCC</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>239227A</drugbatchnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 60 ML  UNIT DOSE: 15 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200712222FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED                           /00016201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED                           /00016201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513867-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>6510 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugdosagetext>10.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugbatchnumb>N62268</drugbatchnumb>
        <drugdosagetext>10 MG/KG</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (GENENTECH)</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>VARIED DOSAGE EVERY DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURINIUM BROMIDE</medicinalproduct>
        <drugdosagetext>50MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENAZPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18422</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>500 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMADRIL</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
        <drugdosagetext>5000 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04229</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>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1000 MG, TX/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC                           /00972401/ (AMLODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPELLIN                        (ACETYLSALICYLIC ACID, CAMPHOR, MENTHO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513878-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4003</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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>154 MG 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>700516</drugbatchnumb>
        <drugdosagetext>550 MG X 4 DOSES IV; TREATMENT BEGAN OCT. 7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>N60635</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200610002383</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH EVENING ; 5 MG, EACH EVENING</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, EACH EVENING ; 5 MG, EACH EVENING</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513882-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3377</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL 100MG TAB</medicinalproduct>
        <drugdosagetext>2 TABLETS DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713216BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHILLIPS LAXATIVE CAPLETS</medicinalproduct>
        <drugbatchnumb>7EAD364</drugbatchnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 1000 MG  UNIT DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513884-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.8748</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugbatchnumb>957827</drugbatchnumb>
        <drugdosagetext>700 MG Q 8 HOURS IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugbatchnumb>928398</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200610001343</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>76.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX /USA/ (ALPRAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.7392</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200609007077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513888-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.9301</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINECARD</medicinalproduct>
        <drugdosagetext>600MG/M2 EVERY 3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIOTOXICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINECARD</medicinalproduct>
        <drugdosagetext>600MG/M2 EVERY 3 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugdosagetext>8MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC STOOL SOFTENER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513890-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200609006133</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>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREST PRO HEALTH RINSE PROCTOR AND GAMBLE</medicinalproduct>
        <drugdosagetext>ONE QUARTER CAPFUL TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>999-091</drugbatchnumb>
        <drugdosagetext>20MG X1 IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>989351</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>18 UNITS/KG PER HOUR IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHONDROMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513895-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200609005180</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE444527JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513897-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00567207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714454BWH</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 200 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR FLUID RETENTION</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513899-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713909BWH</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</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA FACIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>RX 4520587</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716752GDS</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513901-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200606006270</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT LOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO /USA/ (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX /USA/ (ALPRAZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513902-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>1 SHOT EVERY 3 MONTHS IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513903-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513904-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513905-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200610005055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC WEEKLY</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>90 MG, 2/W, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugbatchnumb>51190DD</drugbatchnumb>
        <drugdosagetext>12.5MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG DIVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
        <drugauthorizationnumb>017116</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>225 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, BID, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE905027JAN05</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>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513909-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071102671</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>2X 100UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>2X 100UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>AO195</drugbatchnumb>
        <drugdosagetext>5 MGS 2 X DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101582</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIBAX</medicinalproduct>
        <drugauthorizationnumb>22106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513913-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513914-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070902386</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL OF 13 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>7 MORE INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513915-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20050400473</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>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLINSAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOSTEP</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>106.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIXUMAB 100 MG VIAL BRISTOL-MEYERS</medicinalproduct>
        <drugdosagetext>800 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</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>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>207735E</drugbatchnumb>
        <drugdosagetext>1 220 MG TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513918-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>40MG QD SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugbatchnumb>D6C648</drugbatchnumb>
        <drugdosagetext>250MG FIRST DOSE IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513920-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugbatchnumb>51190DD</drugbatchnumb>
        <drugdosagetext>25MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513921-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0583977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513922-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071105</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-03964</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76449</drugauthorizationnumb>
        <drugdosagetext>10 MG (2.5 MG,4 IN 1 DAY)</drugdosagetext>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE                  (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE                 (RILMENIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513924-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200610004179</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR /AUS/ (BUSPIRONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975370</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>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975404</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>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513927-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13972617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANULOCYTE CSF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513928-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101192</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </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>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071006742</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13972526</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>19763</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>EXTRANODAL NK/T-CELL LYMPHOMA, NASAL TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>EXTRANODAL NK/T-CELL LYMPHOMA, NASAL TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>EXTRANODAL NK/T-CELL LYMPHOMA, NASAL TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>EXTRANODAL NK/T-CELL LYMPHOMA, NASAL TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPLOMYCIN SULFATE</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>EXTRANODAL NK/T-CELL LYMPHOMA, NASAL TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>56 GY=56 DOSAGE FORM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13977061</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13977533</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>GASTRIC MUCOSAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-02667</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>1600200</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>1600200</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513934-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2007-01781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513935-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13975156</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2007-03548</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>CONTRACTED BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>CARCINOMA IN SITU OF BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513937-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13976907</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIP NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13976725</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN INJ</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13978663</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>50443</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513940-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-BRISTOL-MYERS SQUIBB COMPANY-13969431</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN</medicinalproduct>
        <drugauthorizationnumb>060108</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>062311</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KANAMYCIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>061901</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513941-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13590286</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugbatchnumb>KD004</drugbatchnumb>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE 600MG/3 DOSES, DOSE REDUCED TO 450 MG ON 06-NOV-2006 25-SEP-2006-ONGOING</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE 100MG/3 DOSES, DOSE REDUCED TO 45 MG/M2 25-SEP-2006-ONGOING</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>25-SEP-2006-ONGOING, 3 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>26-SEP-2006-ONGOING, DAILY DOSE 6 MG/3 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513942-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BRISTOL-MYERS SQUIBB COMPANY-13976386</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13946405</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugindication>LEIOMYOSARCOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASBURICASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513945-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13484183</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CDDP</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060717</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060721</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANBEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMOCTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XUMADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513946-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T07-USA-03038-01</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>77.3837</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY CASTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY SEDIMENT PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>28 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513948-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13977608</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DOSE: 30 MG; TABLET</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>DOSE: 20 MG;  TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUITEL</medicinalproduct>
        <drugdosagetext>DOSE: 20 MG; TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>DOSE: 1.5 MG; TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPECYCLAL</medicinalproduct>
        <drugdosagetext>DOSE: 300 MG; CAPSULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13978945</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513950-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13974621</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>RECEIVED 3 MONTHS OF TREATMENT</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>GIVEN FOR LAST 8 MONTHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>1 DOSAGEFORM = 0.75 (UNITS NOT SPECIFIED), GIVEN FOR 1 YEAR</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>GIVEN FOR 10 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>GIVEN FOR 10 MONTHS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513951-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13975099</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugauthorizationnumb>18768</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975941</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>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>21-JUL-2007 - 75 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513953-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-BRISTOL-MYERS SQUIBB COMPANY-13914908</companynumb>
    <primarysource>
      <reportercountry>SERBIA</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATINEX</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugdosagetext>80MG/M2,REPEAT THERAPY ON 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA OF SKIN</drugindication>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDASAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANISAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARTMANN SOLUTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-ELI_LILLY_AND_COMPANY-MY200711001818</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE392622JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021111</drugenddate>
        <drugtreatmentduration>1987</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070803884</companynumb>
    <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903728</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>CONTROL NUMBER 7837540</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904502</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>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 4 IN 1 DAY</drugdosagetext>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 4 IN 1 DAY</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070703454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 3 IN 1 DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 3 IN 1 DAY</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 3 IN 1 DAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG, 3 IN 1 DAY</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513968-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070704942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2 IN 1 DAY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513969-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070605249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>TOOK FOR YEARS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>TOOK FOR YEARS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>TOOK FOR YEARS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001385</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>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513971-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000918</companynumb>
    <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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513972-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001715</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13975057</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513974-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070502348</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN IB</medicinalproduct>
        <drugdosagetext>1200 MG, 2 IN 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513975-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070902996</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>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETWEEN SEP AND DEC 2006</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071001488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROWASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070405755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE445327JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE446427JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-200716664GDS</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>BRADYCARDIA FOETAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugauthorizationnumb>020198</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 40 MG  UNIT DOSE: 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070402365</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>, 1 IN 1 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>, 1 IN 1 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070400655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugdosagetext>4 MG, 1 IN 1 DAY</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BRISTOL-MYERS SQUIBB COMPANY-13958368</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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>574</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>NO.OF DOSAGE=D1+D2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>574</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>NO.OF DOSAGE=D1+D2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>574</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENMIX</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 20 UNITS MORNING DOSE AND 10 UNITS EVENING DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513984-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003383</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 LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYNORM CAPSULES 10 MG</medicinalproduct>
        <drugbatchnumb>138244</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513985-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US07182</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP13953</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US13359</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>92.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513988-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US07182</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</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>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007RL000309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^A LOT OF OTHER MEDICATIONS^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00207034527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23945</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>116.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 2.5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPOGONADISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 3.75 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 81 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  37.5/325 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1000 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 145 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070612</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .9 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 320 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .45 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>491</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 15 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200711001076</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE886920APR06</companynumb>
    <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 IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRALATERAL BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513993-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007RL000074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugdosagetext>225 MG;TID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007RL000034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513995-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000355</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>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGDALAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PURDUE-MAG_2007_0000553</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>160 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>120 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061107</drugenddate>
        <drugtreatmentduration>99360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060814</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060718</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>50 MG, AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060418</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060129</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE HCL ELIXIR</medicinalproduct>
        <drugdosagetext>90-160 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>99 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051206</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIKENCHUTO</medicinalproduct>
        <drugdosagetext>7.5 GRAM, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
        <drugtreatmentduration>356</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERIPROCT</medicinalproduct>
        <drugdosagetext>2 GRAM, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMORRHOIDS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061105</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060223</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060509</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORNOXICAM</medicinalproduct>
        <drugdosagetext>12 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
        <drugtreatmentduration>67680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>2 GRAM, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060731</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060119</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060126</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060323</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugdosagetext>100 MCG, DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>180 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513997-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000361</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>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK250997</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5513999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200618154GDDC</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>79.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugbatchnumb>CO4007M600B11</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOMATOLOGICALS, MOUTH PREPARATIONS</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 2; DAILY DOSE UNIT: TABLESPOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALT AND SODA</medicinalproduct>
        <drugdosagetext>DOSE QUANTITY: 2; DAILY DOSE UNIT: TABLESPOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200619978GDDC</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>75.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugbatchnumb>CO4007M600B11</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE: 375/25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200720274GDDC</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>102.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugbatchnumb>C04008M600B11</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-AMGEN-UK251012</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO ; 550 MG;QD;PO ; 325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO ; 550 MG;QD;PO ; 325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO ; 550 MG;QD;PO ; 325 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514004-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000335</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>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/CHONDROITIN /01625901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-AMGEN-UK250989</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTIM</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU248279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714235BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (STUDY MED NOT GIVEN)</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 10 MG</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 175 ?G</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>AS USED: 10/20 MG</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 10 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 10 MEQ</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 5 MG</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUZONE</medicinalproduct>
        <drugindication>INFLUENZA IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>P082312</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-AMGEN-UK247590</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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000344</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>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>225 MG;BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL /01621601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC /00661201/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2006RL000345</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>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL SR</medicinalproduct>
        <drugauthorizationnumb>21416</drugauthorizationnumb>
        <drugdosagetext>425 MG;BID</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL              /00014302/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK246772</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-UK251026</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT HYPEREXTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTIM</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514014-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249368</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 GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXERCALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2001021023</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>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATORY PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010208</drugstartdate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATORY PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010208</drugstartdate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00573007</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTES MATURATION ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNOSIDE A</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00567207</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003BE16287</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA01839</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070116</drugenddate>
        <drugtreatmentduration>258</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713482FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEPTOSPIROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugauthorizationnumb>050547</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEPTOSPIROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKLIN                            /00391001/</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEPTOSPIROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200712537US</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTITUSSIVES AND EXPECTORANTS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: ONE TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN DM</medicinalproduct>
        <drugbatchnumb>UKNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPACOL MENTHOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA                            /01314201/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEIRIA                             /00598401/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACIAL CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070305182</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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070303232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070301805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>, 1 IN 1 TOTAL</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE                  (FOLATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY ASPIRIN                     (ASPIRIN) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN                    (INSULIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLSALIDE 0.6 MG</medicinalproduct>
        <drugdosagetext>0.6 MGBID-QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070204463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA                    (HYPNOTICS AND SEDATIVES) TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECONGESTANT                   (XYLOMETAZOLINE HYDROCHLORIDE)</medicinalproduct>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientweight>93.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE MALEATE/ BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5/10 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30 MG ONE A DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30 MG ONE A DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>65.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY STEROID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN 10/80 MERCK/SCHERING-PLOUGH</medicinalproduct>
        <drugdosagetext>10/80 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN 10/80 MERCK/SCHERING-PLOUGH</medicinalproduct>
        <drugdosagetext>10/80 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>7.5MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDASARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514031-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070106545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.9665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>2400 MG</drugdosagetext>
        <drugindication>JOINT INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugbatchnumb>51190DD</drugbatchnumb>
        <drugdosagetext>25MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE   A LOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG  1 A.M., 2 P.M.  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007307</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A258322</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200711000994</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
        <drugtreatmentduration>474</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707002901</companynumb>
    <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312114</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A357727</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707003562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A264054</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTROL /00538901/</medicinalproduct>
        <drugindication>INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707004600</companynumb>
    <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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY THERAPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A312114</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007414</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY FAT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A255470</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugindication>MULTIPLE FRACTURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007444</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>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200705003642</companynumb>
    <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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709002494</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A341621</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>98.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>172.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>750MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061205243</companynumb>
    <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>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>70529A</drugbatchnumb>
        <drugdosagetext>100 MG Q6 HOURS PRN PAIN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250863</companynumb>
    <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 TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514052-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE392722JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030825</drugenddate>
        <drugtreatmentduration>2177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE662130JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061106488</companynumb>
    <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>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAUSCH-2007BL003933</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>040070</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514056-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL VESSEL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODIXANOL 320MGI/ML AMERSHAM HEALTH</medicinalproduct>
        <drugdosagetext>150ML ONCE IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLICIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NS PLUS D5W</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514057-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>25MG 1XDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061006400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>271203H</drugbatchnumb>
        <drugdosagetext>440-660MG DAILY FOR A ^COUPLE OF YEARS^</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>100MG -1MG/KG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>100MG -1MG/KG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN ANESTHETIC</medicinalproduct>
        <drugdosagetext>ONCE IT</drugdosagetext>
        <drugadministrationroute>038</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRN NARCOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061100473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>2X/DAY OR AS NEEDS TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTNER STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>2 PER DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2004UW20300</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>DSTAB  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70MG  QWEEK  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70MG  QWEEK  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG  EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514070-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG  EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-UK244942</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOST CREMA 2S</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40MG  EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50/75MG  EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200MG  EVERY DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514075-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-US158450</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </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>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514076-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717899US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AVENTIS-200720106GDDC</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20905</drugauthorizationnumb>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712997JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717891US</companynumb>
    <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>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514081-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200720155GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US251933</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250526</companynumb>
    <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 NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250727</companynumb>
    <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>SOFT TISSUE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-AMGEN-US252115</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UPTO 600 MG/DAY AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0503114526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANDIOSITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-AMGEN-US252118</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US244213</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APTECIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRSOGLADINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>PFA095</drugbatchnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugdosagetext>100+100+50</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0635271</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugauthorizationnumb>017821</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCLONUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708390</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708390</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>0708390</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514097-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0631901;0631901</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>0631901;0631901</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>ESGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514098-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071002414</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>1X 100UG/HR PLUS 1X 25UG/HR PATCHES</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>1X 100 UG/HR PATCH PLUS 1X 25 UG/HR PATCH</drugdosagetext>
        <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>
        <drugdosagetext>1X 100 UG/HR PATCH PLUS 1X 50 UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070305451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN PUMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070102959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514101-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071005021</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>CYCLE 1, 40 MG/M2 OVER 4 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US214235</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070125</drugstartdate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOSITOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE TAB</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040464202</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>82.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY MORNING AWAKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 15 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 15 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>48 U, DAILY (1/D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200709001329</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514108-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200708006102</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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG ; 2.40 MG ; 60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG ; 2.40 MG ; 60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13977624</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514110-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200708005600</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</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>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200708003760</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200708003488</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13975164</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13976980</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BRISTOL-MYERS SQUIBB COMPANY-13934161</companynumb>
    <primarysource>
      <reportercountry>INDIA</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 21-SEP-2007 AND AGAIN RESTARTED ON 01-OCT-2007.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13976022</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOOSPERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
        <drugindication>THROMBOCYTHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13977566</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>GASTRIC MUCOSAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13977863</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM EQUALS AUG. FIRST DOSE 17-SEP-2007 - ONGOING.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>FIRST DOSE 17-SEP-2007 - ONGOING.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13978564</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSMOTAN G</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIPLEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13970033</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS LEUKOPENIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>20262</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976840</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>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13978911</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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200708001132</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTON (OXYBUTYNIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL /SCH/ (PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13974795</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981221</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
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        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
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        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
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        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
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        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
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    <safetyreportid>5514144-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200612003359</companynumb>
    <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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200612002776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200612002137</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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAUSCH-2007BL003907</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>040070</drugauthorizationnumb>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H01090407</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>021174</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070616</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGARAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETALAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2007-0013783</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25681</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514151-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAIR, SKIN AND NAIL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIP</medicinalproduct>
        <drugdosagetext>10-25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514152-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP05899</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCHONDRIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200612000055</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200611004655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPETITIVE SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL ; 140 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL ; 140 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PCP (CODEINE PHOSPHATE, PHENAZONE, PHENOBARBITAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200611002077</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200715870GDS</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101529</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KIDNEY INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071101034</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>5 CYCLES ADMINISTERED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAKTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFIPRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071101329</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugauthorizationnumb>20657</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514161-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070705183</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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061105781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061002400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.13</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070603810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103518</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713603BCC</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER PLUS COLD EFFERVESCENT TABLETS</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 500 MG  UNIT DOSE: 250 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514167-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200611001331</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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOTICS AND SEDATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200611000117</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM /NET/ (DIAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-529671</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-529677</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugauthorizationnumb>020136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020136</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS FILM-COATED TABLETS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENITEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-529129</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>017533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-521732</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071102390</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugauthorizationnumb>21169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-527592</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>FORM REPORTED AS F. C. TABS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>REPORTED AS CARDIOVASCULAR AGENT NOS.</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-530458</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED TRANSIENTLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugauthorizationnumb>18164</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-431959</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSTROPHIA MYOTONICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM RISEDRONATE</medicinalproduct>
        <drugdosagetext>CLARIFIED AS 'BENET (SODIUM RISEDRONATE HYDRATE)'</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWATENE</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS 'ORAL'</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>CLARIFIED AS 'MAGLAX'</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>DRUG: MIKAMETAN. NOTE: DOSE ADJUSTED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS LYZYME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE</medicinalproduct>
        <drugdosagetext>REPORTED AS ORAL FORMULATION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILETINE HCL</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS MELDEST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugdosagetext>DRUG NAME: ELTACIN. DOSE ADJUSTED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORID</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS FLORID-D, NOTE: DOSE ADJUSTED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-529328</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</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>IBANDRONATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-529036</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-528919</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUTRITIONAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514182-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-523759</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>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514183-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250959</companynumb>
    <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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEPIDEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514185-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-512903</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711233US</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C1992</drugbatchnumb>
        <drugdosagetext>51 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTYLANE</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETACAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529213</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>CELLCEPT WAS FIRST SHIPPED FROM THE PHARMACY TO THE PATIENT IN MARCH 2006, HOWEVER, THE THERAPY BEG+</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-526170</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>57.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugdosagetext>STRENGTH: 3 MG/3 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529154</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250964</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514191-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-507531</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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>20MG BID FOR ONE MONTH, THEN 20MG TID FOR ONE MONTH, THEN 40MG BID(2 IN AM AND 2 IN PM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ACCUTANE DOSAGE NOT PROVIDED FOR JULY 2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTRET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514192-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-519560</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>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514193-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710784BYL</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>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 300 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 100 MG  UNIT DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID G</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 25 MG  UNIT DOSE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 15 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 40 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 20 MG  UNIT DOSE: 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIPOLAZIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 6 MG  UNIT DOSE: 3 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOR-ADRENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLIVES K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO HEPARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRALIPID 10%</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMINAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514194-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071100818</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019735</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514195-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070305956</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070211</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514196-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>15.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENAMEL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514197-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713399BCC</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>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514198-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200710823BYL</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514199-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-502322</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIVASCULAR DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>PATIENT REPORTED ON 180 MCG PER WEEK.  NO DOSING INFORMATION PROVIDED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^ALOH^</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^TRISIL^</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423701-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG EVERY OTHER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>2.5 MG EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>18 MCG DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 - 50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>2 SPRAYS DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugdosagetext>INHALER AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250963</companynumb>
    <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 INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200705002456</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF SEXUAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200705001498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY (1/D), ORAL ; 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514207-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-529013</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514208-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-528688</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAYS ONE TO FOURTEEN EVERY THREE WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAY ONE EVERY THREE WEEKS. DOSAGE FORM REPORTED AS: INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>GIVEN ON DAY ONE EVERY THREE WEEKS. DOSAGE FORM REPORTED AS: INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-529384</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514210-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200704004655</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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ASTRAZENECA-2007SE05961</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>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED SSRI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26055</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE OPTHALMIC 2.5%</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOPINE HS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26024</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTIGRAS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORC VISION BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5%</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01355</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22369</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514219-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ASTRAZENECA-2007UW26140</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>688</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC A</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26062</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>1 PERCENT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514222-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26030</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTIGRAS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>D.O.R.C. VISION BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26054</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE OPTHALMIC 2.5%</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE05579</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25713</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 4</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETALAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514225-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01465</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23783</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERONEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSFOMYCINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-268996</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERX SOLUTION 2.6 MG/STRIP</medicinalproduct>
        <drugdosagetext>56 IU, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>273</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>12 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRINE                           /00002701/</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN-S</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACOMBI                         /00045401/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-NOVOPROD-268645</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>17 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514228-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-269149</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>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>1.2 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>2.4 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5514229-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268906</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>ANTI-INSULIN ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugauthorizationnumb>19991</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514230-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-NOVOPROD-269160</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>8 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN                            /00646001/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>5514233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200704004908</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>5514235-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200703006583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
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        <drugindication>DEPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5514236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-NOVOPROD-269215</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
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        <drugindication>MEDICATION ERROR</drugindication>
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        <drugstartdate>20070406</drugstartdate>
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        <drugenddate>20070406</drugenddate>
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  <safetyreport>
    <safetyreportid>5514237-1</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedate>20071113</receivedate>
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    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007213</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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514238-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007680</companynumb>
    <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>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711001786</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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA NON-RESECTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA NON-RESECTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007399</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>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-ELI_LILLY_AND_COMPANY-TN200711000332</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-HYDAN</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALPEROS D3</medicinalproduct>
        <drugdosagetext>UNK UNK, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514242-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007163</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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711001058</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN ADENOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060516</drugenddate>
        <drugtreatmentduration>464</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>3 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WASSER V GRAN.</medicinalproduct>
        <drugdosagetext>3 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>3 G, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOGAR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOBUN A</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514244-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000615</companynumb>
    <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708005840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200703006668</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>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200703005923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514250-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0518</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200702002914</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>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200702002939</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>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>508177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL (CHINAPRYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS (MULTIVITAMIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG (GENERIC UNKNOWN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>509136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200702001667</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>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>510572</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>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>1 PER 3 MONTH INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>5514259-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>511870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830615</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA (ABATACEPT)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM LA (DILTIAZEM)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5514260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>512430</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>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>OTHER</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>5514261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
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    <companynumb>512442</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>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514262-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>512449</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200707000104</companynumb>
    <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF PROPRIOCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDODEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) 60 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>512690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>OTHER</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>516850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706005698</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLUNTED AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHAGOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18396</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) ; 20 MG, QOD ; 80 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18396</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) ; 20 MG, QOD ; 80 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18396</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) ; 20 MG, QOD ; 80 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18396</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) ; 20 MG, QOD ; 80 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18396</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D) ; 20 MG, QOD ; 80 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN (PROMETHAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE (POTASSIUM CHLORIDE UNKNOWN FORMULATION) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 7/7/7 (ETHINYLESTRADIOL, NORETHISTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN (ERYTHROMYCIN UNKNOWN FORMULATION) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL /USA/ (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANQUISH (ACETYLSALICYLIC ACID, ALUMINUM HYDROXIDE GEL, DRIED, CAFFEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL /00109201/ (IBUPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENADRINE RFA-1 (ACETYLCARNITINE, CITRUS AURANTIUM, EPHEDRA SPP., LEVO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>519992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROID (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514268-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>521811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>3 MG 1 PER 3 MONTH INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET (DEXTROPROPOXYPHENE/PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12 (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706005809</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D_</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514270-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710002296</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514271-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711000410</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514272-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE705630NOV04</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>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>522934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514274-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071007593</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514275-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-JNJFOC-20071101030</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
        <drugindication>TINNITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514276-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071101483</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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-JNJFOC-20071101833</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20071101849</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514279-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071102397</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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071102587</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDUCT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514281-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071103055</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514282-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTA HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20070905858</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ICHTHYOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514284-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514285-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20071005228</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514286-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CS-JNJFOC-20070900401</companynumb>
    <primarysource>
      <reportercountry>SERBIA AND MONTENEGRO</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514287-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903020</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>63.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITRIC ACID URINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>TWO 200 MG TABLETS IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>400 MG ONCE DAILY; 200 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>200 MG TABLETS FOUR TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>2-3 DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>RENAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0711233US</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C1992</drugbatchnumb>
        <drugdosagetext>51 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RESTYLANE</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETACAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>570 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANGRELOR VS PLACEBO (CODE NOT BROKEN)</medicinalproduct>
        <drugdosagetext>9.2 ML, BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANGRELOR VS PLACEBO (CODE NOT BROKEN)</medicinalproduct>
        <drugdosagetext>151.28 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>4 TABLETS,SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>4 TABLETS, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABRITOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX                           /01263201/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN                             /01319601/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>489849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706005308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3/D ; 800 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514292-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071102</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>496601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>21858</drugauthorizationnumb>
        <drugdosagetext>3 MG 1 PER 3 MONTH INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514294-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706005208</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>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00061</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00050</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050430</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050504</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050419</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050523</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0703USA00854</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>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070507</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugauthorizationnumb>011835</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646066A</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA04388</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>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646090A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0706USA03764</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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>437</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646099A</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646189A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646242A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646259A</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646277A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP1902</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646278A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070318</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646286A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646296A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646601A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514313-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646707A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514314-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646831A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514315-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646878A</companynumb>
    <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646890A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514317-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646990A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A274944</drugbatchnumb>
        <drugdosagetext>30MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514318-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647022A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514319-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647184A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647196A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514321-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647199A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647211A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647278A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647285A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647286A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647409A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>37.5MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514327-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647430A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514328-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647439A</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>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647441A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514330-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647626A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060909</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANDEL CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647638A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647657A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514333-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647658A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514334-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647664A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514335-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647693A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514336-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647802A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514337-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647803A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647812A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647816A</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>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647819A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647826A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647832A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514343-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647842A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647845A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514345-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647901A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647998A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514347-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648001A</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648003A</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514349-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648005A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514350-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648010A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070324</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514351-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648017A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648082A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648168A</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>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648172A</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648175A</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>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648183A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648360A</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>ELEVATED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648376A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648379A</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>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648536A</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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514361-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648537A</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>71.4</patientweight>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648555A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514363-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648587A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648699A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648885A</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648898A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514367-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648912A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649107A</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>
      <patientweight>51.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
        <drugdosagetext>4MGH SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649112A</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649283A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649295A</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649302A</companynumb>
    <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>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649313A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649483A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649486A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649492A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649539A</companynumb>
    <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649696A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649733A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649752A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649778A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
        <drugtreatmentduration>209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-21</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649861A</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514384-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649863A</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649892A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649973A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649978A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649981A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP1902</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514389-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649996A</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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514390-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650243A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514391-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650254A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514392-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650264A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>ST09599</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650269A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>R276081</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650299A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650332A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650453A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650463A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650489A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650499A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650527A</companynumb>
    <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514402-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650616A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650624A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650814A</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>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650824A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514407-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650829A</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 GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650830A</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>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650879A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125U TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514410-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650997A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651031A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651042A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>9.375MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EJECTION FRACTION DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLACK COHOSH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514413-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651049A</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651059A</companynumb>
    <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651069A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651188A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>326</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651247A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651406A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651419A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651555A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651563A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651582A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651586A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKWOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651672A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA03545</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651758A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071007829</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651779A</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>12.5MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>4APP PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>5MG AS REQUIRED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-268947</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20741</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>75 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>95 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT BETA</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514430-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651789A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651834A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651859A</companynumb>
    <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>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652000A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>X9550</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>X7295</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652043A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652121A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652124A</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</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>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652146A</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>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652148A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652156A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652166A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652216A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652231A</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>66.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>X7229</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070521</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652337A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652356A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652369A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652408A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652440A</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>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652645A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652854A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652916A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653033A</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>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653181A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653245A</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>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653264A</companynumb>
    <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 INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653484A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALACEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514457-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653514A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653521A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514459-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653522A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653524A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514461-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653664A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514462-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653710A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514463-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653740A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FER-IN-SOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514464-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653752A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653766A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653782A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE INADEQUATELY CONTROLLED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653811A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653814A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654072A</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706004941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL ; 60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D), ORAL ; 60 MG, DAILY (1/D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654083A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654134A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654161A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706004936</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706002798</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200706000635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN (DICHLORALPHENAZONE, ISOMETHEPTENE, PARACETAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071106</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US200705002024</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514485-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugauthorizationnumb>020937</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-SANOFI-SYNTHELABO-A01200712425</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>D6C451</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2007BH006924</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HAEMOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAUSCH-2007BL003907</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>040070</drugauthorizationnumb>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423682-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <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>20060417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-268920</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>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>TP51348</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTALIP</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682011A</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>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UREA PEROXIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>001</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691978A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7E12</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693825A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693827A</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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7F05</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693880A</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7H17</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694013A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG FIFTEEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694022A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>15GUM PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694057A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTENE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7C28B</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694126A</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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7G03</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694162A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694187A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493761A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423720-00</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514510-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0424135-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0424022-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG EVERY OTHER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>36 MG TWICE DAILY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>4.5 MG EVERY 6 HOURS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>500 MG 2 TABS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-NORTRIPTYLINE</medicinalproduct>
        <drugdosagetext>35 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>120 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RATIO-CYCLOPENZAPRINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVA-SENNA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514512-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-JNJFOC-20071101463</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101566</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCLERITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DO-ROCHE-512120</companynumb>
    <primarysource>
      <reportercountry>DOMINICAN REPUBLIC</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION PARASITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976238</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>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>016979</drugauthorizationnumb>
        <drugdosagetext>ORAL SUSPENSION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13956735</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugauthorizationnumb>19880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugauthorizationnumb>062926</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugdosagetext>1.8GM 2/1DAY FROM 14/SEP/2006-27/SEP/2006</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060928</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROLEPTAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060915</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM</medicinalproduct>
        <drugauthorizationnumb>018654</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007NO16169</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975677</companynumb>
    <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514520-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13940051</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>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 1MG TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 1 MG TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 2.5 MG TABS</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13977418</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER MOTOR NEURONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976824</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>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13976527</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM =396 (UNIT NOT SPECIFIED). FREQUENCY = EVERY 14 DAYS(CYCLICAL)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM=3520(UNIT NOT SPECIFIED; FREQUENCY = EVERY 14 DAYS(CYCLICAL)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 264(UNIT NOT SPECIFIED); FREQUENCY = EVERY 14 DAYS(CYCLICAL)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>FREQUENCY EVERY 7 DAYS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>FREQUENCY EVERY 14 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13976915</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514528-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14511</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>74.829</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORTON'S NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>320MG VAL/12.5MG HCT, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976832</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>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0431159A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL REDUCING AGENT NAME NOT KNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0440056A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0521201A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KELOID SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981114</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0670649A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>7ZP0350</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0678117A</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>7ZP2529</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0681584A</companynumb>
    <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>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CORONARY ARTERY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514536-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682445A</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugbatchnumb>RP054377A</drugbatchnumb>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0682743A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0683947A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687578A</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688276A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689234B</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>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514542-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0689795A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>7ZP4490</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0691021A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugauthorizationnumb>021107</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692260A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692263A</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>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R296317</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514546-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692946A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION FREQUENCY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692964A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692966A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692978A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020781</drugauthorizationnumb>
        <drugdosagetext>8MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693016A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694000A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694014A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>IMLMPWM</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694018A</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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694020A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694040A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694043A</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694198A</companynumb>
    <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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY CORNEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061004</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694263A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694267A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051121</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INJURY</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>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694272A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</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>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061016</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359421A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359423A</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0384561A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050526</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCHIN-KO-TO</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050825</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0439517A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0482481A</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>1.5G UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC ACIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>50MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486607A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugauthorizationnumb>21433</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS TURBUHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486894A</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487068A</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>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</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>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487471A</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>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</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>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAP (RED BLOOD CELLS)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487473A</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>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSLOT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487623A</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>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOWARAT L</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487948A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF PROPRIOCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20103</drugauthorizationnumb>
        <drugdosagetext>8MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>130MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1.8G CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugdosagetext>590MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490063A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490862A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>400MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN</medicinalproduct>
        <drugdosagetext>960MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTIRETROVIRALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491211A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492325A</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>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492626A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSPOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492627A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LULLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492629B</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>125MG TWICE PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH ILETIN II</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494598A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494599A</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>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494689A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494691A</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WINTERMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494862A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE TOXIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAL ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR FORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOPROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494925A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070707</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETORNAN</medicinalproduct>
        <drugdosagetext>2SAC PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugdosagetext>5AMP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494931A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVAMYCINE</medicinalproduct>
        <drugdosagetext>1.5U6 THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIBACTERIAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIBACTERIAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIBACTERIAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494938A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494940A</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>6MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494972A</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494977A</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>297239</drugbatchnumb>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>1.2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERRATIOPEPTIDASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514593-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495106A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugauthorizationnumb>50558</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0052359A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugauthorizationnumb>020236</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0055068A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE200707004957</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS</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>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>489</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-CURE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZOLAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200707004861</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1653 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711000407</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>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200711001169</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTI-ORGAN FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ELI_LILLY_AND_COMPANY-PT200711001084</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE W/SALMETEROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200711000227</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200709006044</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>60 MG, 2/D</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D(3)</medicinalproduct>
        <drugdosagetext>2 D/F, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE200710006923</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL 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>20070614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710007639</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>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE CUP/DISC RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE SHEATH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE200709003183</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</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>20060803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO200708000590</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A287016</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200708003552</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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</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>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070805</drugenddate>
        <drugtreatmentduration>318</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>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000717</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200711000779</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>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</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>20061002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH200710002545</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>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>1000 MG, EVERY FOUR WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPHAMESON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-LLY01-FR200709003758</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200720309GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200619770US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>E075</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE: 19 QAM AND 17 QPM VIA PEN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>40E011</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE: VIA VIAL AND SYRINGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTICLIK (INSULIN INJECTION PEN)</medicinalproduct>
        <drugbatchnumb>D029</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: W/MEALS AND SNACKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AVENTIS-200712637DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX 5</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708002352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>LIMB CRUSHING INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A241867</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007093414</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE/FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL DEPOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2007091919</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093576</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007033778</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>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTEROCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>TEXT:2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEIACT</medicinalproduct>
        <drugdosagetext>TEXT:3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLANTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugbatchnumb>IB53884</drugbatchnumb>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007075699</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>ALCOHOL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NALTREXONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</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>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN T</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAREL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>C708578</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-0712358US</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugauthorizationnumb>020613</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007070061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007074574</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26026</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>1 %</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugdosagetext>2 %</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISCIN BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCT</medicinalproduct>
        <drugdosagetext>2.5 %</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-HYDRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01556</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29774</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26029</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26056</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL 2.5%</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-SALVENT CFC FREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVASEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01582</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>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07141</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>301</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26053</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSORCAINE</medicinalproduct>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugadministrationroute>008</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25542</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06930</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ASTRAZENECA-2007PK01900</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26057</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>2%</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTIGRAS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE 2.5%</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ASTRAZENECA-2007SE05547</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>4.9 MG/KG</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>GIVEN IN COMBINATION WITH MARCAIN</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26028</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTIGRAS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>D.O.R.C. VISION BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION: BLOCK + INFILTRATION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE OPTHALMIC 2.5%</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW28080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060918</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABT-335</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060918</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>5.25/37.5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-SOLVAY-00207034273</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24079</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugauthorizationnumb>20184</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 8 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 432 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 40 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13976121</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>NOT CONTINUING THE DRUG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007074306</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE447727JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-13970918</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007065825</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE BROMIDE</medicinalproduct>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007058921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093187</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>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007066220</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006124781</companynumb>
    <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A0006</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROAMPHETAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007027698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0600419US</companynumb>
    <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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugdosagetext>20 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>2.5 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19720101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093811</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>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092549</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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011856</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>DAILY DOSE:44MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:8I.U.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW26168</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007052658</companynumb>
    <primarysource>
      <reportercountry>IRELAND</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>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093591</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>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007044745</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:50</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:75MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076028</companynumb>
    <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>CHEST EXPANSION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECG SIGNS OF MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007093345</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093368</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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>FREQ:EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007084632</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007081906</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080700</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007079945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007080126</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:75MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>TEXT:2 DOSES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007077695</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTROCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH RETARDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0424025-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007091831</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007091687</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMYLASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007090548</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007090830</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089356</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL TENSION GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPHTHALMOLOGICALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-ADRENORECEPTOR ANTAGONIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007089729</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>11971</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:37.5MG-FREQ:CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D6D612</drugbatchnumb>
        <drugdosagetext>DAILY DOSE:140MG-FREQ:CYCLIC EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-H01036507</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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089642</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>86.363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088437</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugauthorizationnumb>008697</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIFLATULENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2007087611</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007085861</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLEAR CELL CARCINOMA OF THE KIDNEY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALAISE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:6MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW26183</companynumb>
    <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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ASTRAZENECA-2007UW26095</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>689</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC A</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC A</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-PFIZER INC-2007085591</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2007092092</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007091933</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>NO401067</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG-FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH006652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENLON-PLUS VIALS</medicinalproduct>
        <drugbatchnumb>61176</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:CUBIC CENTIMETER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA REVERSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092410</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093950</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093544</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL TENSION GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2007093613</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>009987</drugauthorizationnumb>
        <drugindication>CHRONIC HEPATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007093506</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>020280</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1.5MG-FREQ:DAILY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093444</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TEXT:0.5MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-07P-161-0419198-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOGYRIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG/DAY, DIVIDED INTO 3 TIMES DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>30 MG/DAY, DIVIDED INTO 3 TIMES DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>AGGRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093342</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2004-0007737</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093087</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRACHEO-OESOPHAGEAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>06-042994</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOID CYSTIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093206</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050778</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:300MG/M2</drugdosagetext>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2007-0013762</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLADDER TRANSITIONAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL200711001074</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.893</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, 2/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001850</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBATRIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>SPINAL CORD INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR200711000477</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</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>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFLURIDOL</medicinalproduct>
        <drugdosagetext>20 MG, WEEKLY (1/W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711001093</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
        <drugtreatmentduration>209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-GILEAD-2007-0014231</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>071576</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXUBERA</medicinalproduct>
        <drugauthorizationnumb>021868</drugauthorizationnumb>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2006-0009189</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-GILEAD-2007-0014293</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEPATITIS CHRONIC PERSISTENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092717</companynumb>
    <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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENILE DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084427</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084427</drugauthorizationnumb>
        <drugdosagetext>TEXT:100 - 150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:800MG</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPTIC AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GILEAD-2007-0013926</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTIDE</medicinalproduct>
        <drugauthorizationnumb>020638</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBULINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007092560</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXERUTINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOSEDYL ^HOECHST^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092505</companynumb>
    <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2007092492</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007094225</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROACT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE445527JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE450127JUL04</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>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE693504MAY04</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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE446127JUL04</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE444427JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>144.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>10413</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>TEXT:6.25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-244327</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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01137007</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>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-SYNTHELABO-A06200700549</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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26059</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIGNOCAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26058</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO HYDRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA200710007343</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRALEX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ELI_LILLY_AND_COMPANY-AT200711001168</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</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>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200711002473</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOGLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200702680</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLUOROURACIL DAKOTA PHARM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLUOROURACIL DAKOTA PHARM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLUOROURACIL DAKOTA PHARM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-SANOFI-SYNTHELABO-A01200712489</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060923</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>IN 500 ML GLUCOSE SOLUTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060924</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706358</companynumb>
    <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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GENENTECH-248935</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENDOXAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-CAN_2007_0000375</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02533</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>90 DF PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMEPRAZINE TAB</medicinalproduct>
        <drugdosagetext>20 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940612</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13975396</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>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11181</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>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076503</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11149</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN TABLETS BP 250MG</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugindication>ENDOCARDITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ENDOCARDITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11161</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>076165</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISPERSIBLE ASPIRIN 75MG TABLETS BP</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 20MG TABLETS</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11216</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL TABLETS BP 100MG</medicinalproduct>
        <drugdosagetext>3200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>1920 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOLO RANBAXY 25 MG COMPRESSE</medicinalproduct>
        <drugauthorizationnumb>076989</drugauthorizationnumb>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>1480 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF MUTILATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070818</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200712440</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-SANOFI-SYNTHELABO-A01200712438</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-249911</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-SANOFI-SYNTHELABO-D01200701346</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVE8062</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-250465</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (UNK INGREDIENT)</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-A01200712589</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-EMETICS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0028165</companynumb>
    <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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-250707</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOID NOS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL STEROIDS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-250886</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>559 MG, QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WYE-G00401507</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMOPAX MONO</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE679806APR06</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU02040</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>12-450MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>3097</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, BID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD MANE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPRO</medicinalproduct>
        <drugdosagetext>400 MG, QD NOCTE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD NOCTE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250914</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>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>400 MG/M2, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2400 MG/M2, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-251006</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>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GENENTECH-251008</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>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-251132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SHR-DE-2007-031562</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-042532</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SHR-ES-2007-038925</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>52313A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-SHR-NO-2007-041986</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>STOPPED BECAUSE OF NUMBNESS IN L</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-042174</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>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-005349</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>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SHR-BR-2007-042468</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, 3X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, 3X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-008863</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-042356</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>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-037077</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SHR-GB-2007-036665</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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 A?G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>5-10 ML, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>40 MG, BED T.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>100 MG, AS REQ'D</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>5 MG, AS REQ'D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SHR-CA-2007-020225</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>1550</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugdosagetext>1 TAB(S), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMROSE OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-001481</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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHR-FR-2007-001045</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>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENSIEL</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-SHR-AT-2007-042132</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239355K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.6005</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>I.U.</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071101-0001249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING ENTEROCOLITIS NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOPROFEN</medicinalproduct>
        <drugauthorizationnumb>21903</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG; 1X; IV, 5 MG/KG; ; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PATENT DUCTUS ARTERIOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX001793</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugbatchnumb>P057615</drugbatchnumb>
        <drugdosagetext>15 UG; QD; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugbatchnumb>P057615</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugbatchnumb>P063699</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugbatchnumb>LOT A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG; QAM; PO, 400 MG; QPM; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG; QAM; PO, 400 MG; QPM; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>158.759</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>18 GM (6 GM, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0424147-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIORIDAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>35 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>35 ML, 1 DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^CLOPIDIDRIL^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041846</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>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042250</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060310</drugenddate>
        <drugtreatmentduration>4195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-020080</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>50.794</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA6215A,WA6951B, WA9730A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033663</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>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-038630</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9002A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA9003A</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5901A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-019514</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-023346</companynumb>
    <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>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-020803</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>BLADDER SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002401</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>6 GM (3 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>6 GM (3 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-016936</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>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4599A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, 2X/WEEK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, 1X/MONTH</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-021154</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VB4733A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-021143</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022301</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-1164204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPHCON-A</medicinalproduct>
        <drugauthorizationnumb>20226</drugauthorizationnumb>
        <drugdosagetext>(OPHTHALMIC)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023220</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023341</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018136</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>BONE CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018826</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>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA2178A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018242</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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
        <drugtreatmentduration>87840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-022663</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>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-042085</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-024386</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>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051231</drugenddate>
        <drugtreatmentduration>1489</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>4 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>30 IU, BED T.</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG/D, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-037044</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>97.506</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RESURFACING SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3846A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, 1X/MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 MG/D, BED T.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugdosagetext>5 MG, AS REQ'D @BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM A TO ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-021895</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>81.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>655</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK, AS REQ'D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE253920JUL04</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE447227JUL04</companynumb>
    <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>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE710503AUG04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE892906JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30855_2007</companynumb>
    <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>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE PEAKED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018893</companynumb>
    <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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021227</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>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>6PHT4</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75  MG/M2;QD;PO ; 1450 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>6PHT4</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75  MG/M2;QD;PO ; 1450 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugbatchnumb>5JFL14</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>TIW;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG;BID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>016831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL ; 40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL ; 40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020049</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugauthorizationnumb>88617</drugauthorizationnumb>
        <drugdosagetext>6.25 - 12.5 MG PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCILIN (DOXYCYCLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04729</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugauthorizationnumb>22000</drugauthorizationnumb>
        <drugdosagetext>2.4 G, 1X/DAY:QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_00952_2007</companynumb>
    <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>77456</drugauthorizationnumb>
        <drugdosagetext>(600 MG BID ORAL) , (DF ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>77456</drugauthorizationnumb>
        <drugdosagetext>(600 MG BID ORAL) , (DF ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>(200 MG BID CAPSULES ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>(1 DF 1X/WEEK 150 MCG/0.5 ML SUBCUTANEOUS), (1 DF 1X/WEEK 150 MCG/0.5 ML SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>(1 DF 1X/WEEK 150 MCG/0.5 ML SUBCUTANEOUS), (1 DF 1X/WEEK 150 MCG/0.5 ML SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY MULTIPLE VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238781K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000588</companynumb>
    <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR200711001462</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A317030</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>21 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>7 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200708005672</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGON</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>7 U, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000122</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.814</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MOVEMENTS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>25 U, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS /01549301/</medicinalproduct>
        <drugdosagetext>1 UNK, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.8 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugindication>COAGULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001609</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A289513</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A289513</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000117</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</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>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN /SCH/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAZACLO ODT</medicinalproduct>
        <drugauthorizationnumb>21590</drugauthorizationnumb>
        <drugdosagetext>300 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A309432</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX                            /01760402/</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE /01735902/</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK, MONTHLY (1/M)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>1 D/F, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/APAP</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>1 D/F, UNKNOWN</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>LIPIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTIN-MEPHA</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN /00082702/</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A300348</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>45 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>45 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugdosagetext>35 U, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugdosagetext>35 U, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>800 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>800 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>300 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>300 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1000 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1000 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>GOITRE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugdosagetext>5 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugdosagetext>5 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710006524</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>8 IU, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 IU, AS NEEDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000831</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN, ANIMAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>17931</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710003493</companynumb>
    <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A300348</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000935</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN (RDNA ORIGIN)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000224</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711002157</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>6 U, OTHER, AT NIGHT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>10 U, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 U, OTHER, AT NOON</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>10 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A349467</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE EXAMINATION ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000637</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A334522</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ELI_LILLY_AND_COMPANY-AR200710001466</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5UG, DAILY EXPECPT ON SUNDAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK UNK, 3/W</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>4000 IU, WEEKLY (1/W)</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>6000 IU, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711000459</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREVILOR</medicinalproduct>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANZYTRAT</medicinalproduct>
        <drugdosagetext>UNK, 3/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711001189</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-251074</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>80 MG/M2, DAYS1,8,15</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
        <drugdosagetext>6 MG, Q4W</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GENENTECH-251077</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>1110 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPAMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DERGOCRINE MESILATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESERPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>89340</drugauthorizationnumb>
        <drugdosagetext>4850MG/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>89340</drugauthorizationnumb>
        <drugdosagetext>4850MG/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071100290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACOGEN</medicinalproduct>
        <drugauthorizationnumb>21790</drugauthorizationnumb>
        <drugdosagetext>20 MG/M2, IN 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05799-01</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8027800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugindication>CEREBRAL PALSY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21505</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CEREBRAL PALSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-251067</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>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0420620A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030811</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001021</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>24 U, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>24 U, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19510101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0563175A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709002936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL BILE LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugbatchnumb>A297166</drugbatchnumb>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>10 UG, 2/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0567256A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, 2/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0582190A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000565</companynumb>
    <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>
        <drugdosagetext>10 UG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0601970A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERA-HS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0606852A</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>81.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051008</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0618763A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620328A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN-CONVERTING ENZYME INHIBITOR (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN-CONVERTING ENZYME INHIBITOR (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620332A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620355A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620519A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620544A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620562A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIPPLE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620568A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620690A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</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>5514884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620729A</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>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW MAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514886-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620862A</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25TAB VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620911A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620970A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060907</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUTROL (ZILEUTON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620971A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620976A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>50MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0620982A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAGLIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621008A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621159A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621199A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621217A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621294A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621301A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621477A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621592A</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>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621694A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP5096</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125VA TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621796A</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621806A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021909</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621815A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621816A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514909-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621864A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621868A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621938A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0621941A</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622108A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622138A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622139A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060630</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622294A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622320A</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>ALCOHOL INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP6889</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622323A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622325A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622358A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622483A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622652A</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622662A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622669A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622766A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622767A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514928-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622824A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622984A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0622992A</companynumb>
    <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>4746V41</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623066A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623102A</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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623104A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623236A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514935-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623382A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623408A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623542A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623543A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623555A</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>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623590A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623716A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623724A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOLFF-PARKINSON-WHITE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623731A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623808A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISO-BID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623884A</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623885A</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>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623901A</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623907A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623921A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623930A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAILY VITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0623969A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE INADEQUATELY CONTROLLED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624062A</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624063A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624218A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>9.375MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624247A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>9.375MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624260A</companynumb>
    <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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624279A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624366A</companynumb>
    <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624372A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624387A</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHRITIS MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624388A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624397A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624562A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624585A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624767A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624895A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624900A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624901A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061014</drugstartdate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0624903A</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>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514971-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514972-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625076A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625197A</companynumb>
    <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 LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WEIGHT LOSS MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625209A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625270A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625354A</companynumb>
    <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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514977-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625382A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625617A</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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625845A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625851A</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>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625861A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625896A</companynumb>
    <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626023A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514984-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626024A</companynumb>
    <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626045A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626046A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626161A</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626180A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626183A</companynumb>
    <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626208A</companynumb>
    <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>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626344A</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060824</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514993-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626355A</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626358A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514995-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626360A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626576A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</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>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626724A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626749A</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>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>32658</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5514999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626751A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515000-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626775A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515001-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626888A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515002-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627018A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515003-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627025A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>RJ0377 DEM</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6 + FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515004-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627031A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627058A</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515006-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627263A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515008-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627270A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515009-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515010-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627297A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515011-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627302A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515012-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627328A</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515013-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627465A</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515014-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627467A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515015-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627471A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627507A</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>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515017-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627655A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMBITROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627676A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627681A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515020-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627819A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515021-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627935A</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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUCLEAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627937A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515023-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628008A</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>65.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515024-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628101A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628127A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515026-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628132A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515027-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628286A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515028-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628303A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628316A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515030-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628318A</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>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515031-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628470A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515033-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628669A</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515034-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628675A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628677A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515036-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628685A</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>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515037-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628690A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY MORNING AWAKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515038-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628699A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515039-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628704A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515040-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628869A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515041-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628978A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515042-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628992A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628995A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629013A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629015A</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629350A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515047-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629429A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629692A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629708A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515050-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629710A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515051-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629922A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629931A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515053-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630074A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515054-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630239A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630253A</companynumb>
    <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515056-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630611A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630622A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630629A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630644A</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>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515060-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630775A</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SIGHS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLICOSANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515061-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630940A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515062-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630960A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN ASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515063-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630971A</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515064-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631146A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA BABY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515065-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631152A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515066-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631235A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631448A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060910</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515068-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631598A</companynumb>
    <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 PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515069-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631614A</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>98.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EJECTION FRACTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631633A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515071-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631653A</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>121.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515072-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631736A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</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>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515073-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631743A</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>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631759A</companynumb>
    <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>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631816A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515076-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631937A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631955A</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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515078-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632012A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515079-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632113A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515080-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632137A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515081-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632156A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632295A</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515083-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632302A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515084-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632464A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515085-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632470A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515086-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515087-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632576A</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515088-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632589A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515089-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632599A</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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632600A</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EJECTION FRACTION DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515091-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632615A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOSITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632619A</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632855A</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 50/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632861A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632976A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633231A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>8206014</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060814</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633243A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW MAG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633766A</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633768A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515100-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634123A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515101-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634136A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENIC SUBSTANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634141A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP6015</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634148A</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634490A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634506A</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515106-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634520A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515107-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634552A</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515108-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634562A</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>81.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515109-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634733A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515110-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634747A</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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515111-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634761A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515112-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634924A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515113-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634925A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515114-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634929A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634938A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634939A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515117-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634947A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515118-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634994A</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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515119-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635030A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515120-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635031A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515121-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635033A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635196A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635347A</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070107</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635358A</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515125-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635362A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635364A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515127-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635366A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515128-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635424A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061213</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515129-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635505A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635506A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515131-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635510A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635514A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635526A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515134-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635552A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635679A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635700A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515137-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635723A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515138-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635738A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515139-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635751A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635859A</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515141-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635863A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635997A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMADYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636145A</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>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515144-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636154A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636180A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636217A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636310A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636337A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636339A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636396A</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>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636405A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636533A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>1</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>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636537A</companynumb>
    <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>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA BABY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636573A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515155-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636698A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636700A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636702A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636705A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636718A</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>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636731A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636858A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYCARBOPHIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515162-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636875A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637021A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515164-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637033A</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515165-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637048A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515166-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637189A</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>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>019583</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637390A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637427A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637447A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637493A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637509A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515173-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637516A</companynumb>
    <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637633A</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 PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515175-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637636A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637654A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637655A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515178-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637656A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637691A</companynumb>
    <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>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250121</companynumb>
    <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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515181-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637788A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515182-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637790A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515183-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637807A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515184-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637811A</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>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515185-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637831A</companynumb>
    <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>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC PACEMAKER INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637976A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637979A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MITRAL VALVE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637989A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515189-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638142A</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638152A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515191-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638174A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515192-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638175A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515193-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638337A</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMOCYSTEINE (MULTIVIT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515194-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638340A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638351A</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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515196-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638360A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638361A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638426A</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638567A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0370025-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</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>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDIN 50/4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENENTECH-249139</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTOPIDIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLLEN NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515202-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-250361</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>670 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOZOP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N38279</drugbatchnumb>
        <drugdosagetext>10 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US10826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC SRT</medicinalproduct>
        <drugdosagetext>ONCE/SINGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423645-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugdosagetext>4 TO 4.5 MG DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017020</drugauthorizationnumb>
        <drugdosagetext>DOSE TITRATED TO TARGET INR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13883848</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>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMSAM</medicinalproduct>
        <drugauthorizationnumb>21336</drugauthorizationnumb>
        <drugdosagetext>6 MILLIGRAM, TD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM, 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHOBID</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM, 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110302</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07041092</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>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, QOD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110231</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>0154B-B</drugbatchnumb>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07110198</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>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515211-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENENTECH-251076</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515212-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYFLO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515213-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07091584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_00694_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APOKYN</medicinalproduct>
        <drugbatchnumb>626006A</drugbatchnumb>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>(0.2 ML BID SUBCUTANEOUS); (0.3 ML QD SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APOKYN</medicinalproduct>
        <drugbatchnumb>626006A</drugbatchnumb>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>(0.2 ML BID SUBCUTANEOUS); (0.3 ML QD SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE MONOHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GENENTECH-218979</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>325 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050412</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>320 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4990 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIANAL C</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-234702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061213</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515217-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11737</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>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOANING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>3017507</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL ^BEER^ (ETHANOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>3017397</drugbatchnumb>
        <drugauthorizationnumb>20076</drugauthorizationnumb>
        <drugdosagetext>21 MG, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11724</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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX REG STR CHOCOLATED LAX PCS SEN (NCH)(SENNA GLYCOSIDES (CA SALTS</medicinalproduct>
        <drugdosagetext>ON AND OFF FOR MANY DAYS, ORAL; 30 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515220-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-239846</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>500 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MTX</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515221-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-239903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>7.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>N25011</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>10 UNIT, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-240807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG, 1/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2500 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>TENSION HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-240807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG, 1/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>1250 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2500 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>TENSION HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-242129</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>40.363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020522</drugauthorizationnumb>
        <drugdosagetext>1.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-243814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>GUILLAIN-BARRE SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-244072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>375 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER PLUS CALCIUM WITH WHEAT DEXTRIN(NCH)(CALCIUM CARBONATE, WHEA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515228-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11692</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERAFLU DAYTIME SEVERE COLD WARMING SYRUP (NCH)(PARACETAMOL, DEXTROME</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515229-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11676</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>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGISTAT-1</medicinalproduct>
        <drugbatchnumb>01068</drugbatchnumb>
        <drugauthorizationnumb>20676</drugauthorizationnumb>
        <drugdosagetext>300 MG, ONCE/SINGLE, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515230-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>842 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>847 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>841 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN ORAL SUSP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07-002133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>86069</drugauthorizationnumb>
        <drugdosagetext>2 GRAMS TWICE A WEEK, VAGINAL, 2 GRAMS ONCE A WEEK, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>86069</drugauthorizationnumb>
        <drugdosagetext>2 GRAMS TWICE A WEEK, VAGINAL, 2 GRAMS ONCE A WEEK, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515232-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8MG, PER ORAL; 16 MG PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022187</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515234-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245937</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>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG/KG, QOW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-246463</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022196</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ITMN-200509IM00057</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>94.8018</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYOGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1</medicinalproduct>
        <drugdosagetext>15 UG;QD; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.1%, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002714</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>0.1%, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-246817</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-246921</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>20 A?G, SINGLE</drugdosagetext>
        <drugadministrationroute>021</drugadministrationroute>
        <drugindication>THROMBOLYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-246953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>10 MG/KG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>90 MG/M2, DAYS1,8,15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002697</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>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-246993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515246-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR200711001075</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGASTRO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515247-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ALLERGAN-0711842US</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTABEX</medicinalproduct>
        <drugbatchnumb>C1797</drugbatchnumb>
        <drugdosagetext>50 UNITS, SINGLE</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023375</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020830</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>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515251-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515252-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROVESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>451 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515253-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0711BEL00012</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>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANITOP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA04354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515255-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA04992</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>IDIOPATHIC NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515256-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00018</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC-XE</medicinalproduct>
        <drugauthorizationnumb>020330</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0711BEL00011</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA02098</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515259-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022629</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>90.7194</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515260-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA02520</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060604</drugenddate>
        <drugtreatmentduration>1238</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0711BEL00013</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA01923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060325</drugenddate>
        <drugtreatmentduration>444</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515263-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0709BEL00022</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010609</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980802</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980528</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980929</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME AXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010312</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME AXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAXILLARY ANTRUM OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010312</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515264-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0711MYS00007</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NOSOCOMIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515265-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA01474</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0711CAN00031</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0710DEU00363</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>
      <patientweight>85</patientweight>
      <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021420</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>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>3.1 MG, 6/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SILVER-RUSSELL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-247580</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515273-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-247587</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>0.9 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515274-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-249759</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-243146</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>60 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CUTANEOUS LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515276-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GENENTECH-251225</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1100 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (UNK INGREDIENT)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (UNK INGREDIENT)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ALLERGAN-0711842US</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTABEX</medicinalproduct>
        <drugbatchnumb>C1797</drugbatchnumb>
        <drugdosagetext>50 UNITS, SINGLE</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-251168</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500 MG/M2, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>25 MG/M2, 1/MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN FORTE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOMITANT DRUG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515279-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-244151</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, 1/WEEK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX (FRANCE)</medicinalproduct>
        <drugdosagetext>2 UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>32 UNIT, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>8 UNIT, PRN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURADANTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515280-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-244364</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515281-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-243161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515282-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-251141</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>275 UNK, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515283-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-224729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN (DIETARY SUPPLEMENT)</medicinalproduct>
        <drugdosagetext>320 UNK, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>400 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
        <drugindication>VAGINAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515284-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24221RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugauthorizationnumb>073591</drugauthorizationnumb>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515285-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROXANE LABORATORIES, INC-2007-BP-24226RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugindication>PEMPHIGOID</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PEMPHIGOID</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROXANE LABORATORIES, INC-2007-DE-06665GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>N-ACETYLCYSTEINE</medicinalproduct>
        <drugdosagetext>150 MG/KG OVER 15 MIN, THEN 50 MG/KG OVER 4 H, THEN 100 MG/KG OVER 16 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>076934</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugdosagetext>1700 ML OF 5%</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24218RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugauthorizationnumb>073591</drugauthorizationnumb>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24220RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugauthorizationnumb>073591</drugauthorizationnumb>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019233</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>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI003414</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003740</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>108.8633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugauthorizationnumb>21476</drugauthorizationnumb>
        <drugdosagetext>3 MG; HS; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18170YA</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN OCR</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIFENACIN (TAMSULOSIN REFERENCE)</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARNIDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRAT</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-16816BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609990B,6C2214</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23043BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705255B</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23052BP</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>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23062BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21409BP</companynumb>
    <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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHINICAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23997BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24261BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515300-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23115BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515301-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-UK-03530UK</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
        <drugdosagetext>2/1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515302-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23457BP</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515303-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23040BP</companynumb>
    <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515304-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21645BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-UK-03542UK</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN (00015/0052R)</medicinalproduct>
        <drugauthorizationnumb>12836</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</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>5515306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21799BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>702151A,703046A,7C2205</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER CAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515307-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23065BP</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515308-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21732BP</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515309-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24063BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515310-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23111BP</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>5515311-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20056BP</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>H0600336</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>PROSTATOMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>H0600336</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIET SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515312-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23057BP</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0608188</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515313-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UG-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23995BP</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515314-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23055BP</companynumb>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>F0700050</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515315-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23878PF</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CARDIAC ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugindication>NASAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515316-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23050BP</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 LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</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>20071013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515317-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-UK-03545UK</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM (00015/0190/A)</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515318-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24361BP</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609823,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515319-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24346BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX NEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515320-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22575MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515321-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23347BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515322-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-05570YA</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN OCR</medicinalproduct>
        <drugbatchnumb>6BN 16209/2</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIFENACIN SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC (BETAHISTINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515323-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21645BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS/RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>21814</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515324-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23378BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515325-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23114BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515326-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23067BP</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>TREMOR</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>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515327-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23064BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609029</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515328-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23016BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515329-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23053BP</companynumb>
    <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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515330-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-17480BP</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665120A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665120A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>665120A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515331-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23095BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515332-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23092BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515333-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23139BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515334-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21846BP</companynumb>
    <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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</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>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>'A LOT' OF OTHER MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515335-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23068BP</companynumb>
    <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515336-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23234BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515337-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23243BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515338-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018667</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>ADNEXA UTERI PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515339-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018488</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32019</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515340-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021492</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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515341-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022264</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>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515343-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32026</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515344-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023212</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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515345-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023330</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>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515346-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI002488</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>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515347-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI006830</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515348-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023398</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>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515349-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023137</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</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>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515350-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515351-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI015604</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515352-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI014892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT SPLENIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515353-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI020204</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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515354-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023417</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>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32022</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515355-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023430</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>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515356-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023438</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515357-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023444</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>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515358-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023448</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515359-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515360-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515361-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023531</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>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515362-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002530</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>9 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515363-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001131</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1 G., BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO (HYDROCODONE BITARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515364-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002686</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>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCAMINE</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN (CASPOFUNGIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515365-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002716</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>77.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugbatchnumb>A23007A</drugbatchnumb>
        <drugdosagetext>0.1 MG/KG, WEEKLY, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM (IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN (CASPOFUNGIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515366-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US020086</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENCE JONES PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>11.5 MG DAILY FOR 7 DAYS INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HC1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR HC1</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE W/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515367-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>0.25 MG/KG UNK INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515368-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US09325</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>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOOTH MUSCLE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>75209</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515369-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US09188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN (NGX)(BENZYLPENICILLIN) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>65079</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515370-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07112292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugbatchnumb>066428</drugbatchnumb>
        <drugauthorizationnumb>40684</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515371-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A01736</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>8 MG, QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515372-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11989</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>66</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>50 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515373-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>2200 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515374-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02196</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>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL; 16 MG, 2 TABLETS QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL; 16 MG, 2 TABLETS QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIDDLE INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL; 16 MG, 2 TABLETS QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugauthorizationnumb>21782</drugauthorizationnumb>
        <drugdosagetext>8 MG, QHS, PER ORAL; 16 MG, 2 TABLETS QHS, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIDDLE INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/MAGNESIUM (MAGNESIUM, CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER-C (CALCIUM ASCORBATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (EROGOCALCIFEROL, ASCORBIC ACID, FOLIC ACID, THIAMINE HYD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515375-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12314</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRASPINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.8 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515376-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007PV00042</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CNS VENTRICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPENDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPOCYT</medicinalproduct>
        <drugauthorizationnumb>21041</drugauthorizationnumb>
        <drugdosagetext>50 MG; X1; INTH</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>METASTASES TO MENINGES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515377-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-163029-NL</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND OVARY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPHIN</medicinalproduct>
        <drugauthorizationnumb>17692</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUTEINISING HORMONE (HUMAN)</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515378-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6039199</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPENON (APRINDINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515379-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04493</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCOSTAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76426</drugauthorizationnumb>
        <drugdosagetext>500 MG TWICE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN) (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADOL (PANADEINE CO) (CODEINE PHOSPHATE, DIPHENYLPYRALINE HYDROCHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHORPRIM (TRIMETHOPRIM) (TRIMETHOPRIM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515380-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#08#2007-04526</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugauthorizationnumb>63187</drugauthorizationnumb>
        <drugdosagetext>200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION BACTERIAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515381-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-167102-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETONOGESTREL (BATCH # 652032)</medicinalproduct>
        <drugauthorizationnumb>21529</drugauthorizationnumb>
        <drugdosagetext>DF SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515382-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163365ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>89081</drugauthorizationnumb>
        <drugdosagetext>12.5 MG (12.5 MG,1 IN 1 D)</drugdosagetext>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>150 MG (150 MG,1 IN 1 D)</drugdosagetext>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515383-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163366ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>76052</drugauthorizationnumb>
        <drugdosagetext>(40 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515384-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>152847ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>75797</drugauthorizationnumb>
        <drugdosagetext>(20 MG) TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515385-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>149452ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>75184</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515386-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163503ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>40333</drugauthorizationnumb>
        <drugdosagetext>(1000 MG/M2) INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>(200 MG/M2) INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>(85 MG/M2) INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515387-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LTI2007A00301</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPETACT (PIOGLITAZONE HYDROCHLORIDE, METFORMIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21842</drugauthorizationnumb>
        <drugdosagetext>45 MG (15 MG, 3 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON (DIOSMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515388-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2007A00971</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>105 MG, OTHER PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPRADOL (KETOROLAC TROMETHAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515389-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2007A04832</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG,1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANSPORIN INTRAVENOUS 1GM. (CEFOTIAM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGACIN (BIAPENEM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515390-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LTI2007A00171</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG,1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515391-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2007A00913</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG ; 30 MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG ; 30 MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN (HYDROCHLOROTHIAZIDE, VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN /SCH/ (SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515392-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2007A05899</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG,1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515393-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR END-DIASTOLIC PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>(, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>585</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>(, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>585</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515394-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638573A</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>64.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG IN THE MORNING</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515395-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638579A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METANX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW MAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515396-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638622A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515397-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638629A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515398-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638631A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515399-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638749A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515400-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638759A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515401-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638766A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515402-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638812A</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515403-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638893A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515404-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638904A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515405-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638907A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515406-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638911A</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>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDIAL EFFUSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515407-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639033A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Q-10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515408-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639034A</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515409-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639040A</companynumb>
    <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 POSTURAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515410-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639043A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515411-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639051A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515412-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639052A</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>98.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URECHOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515413-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639194A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515414-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639197A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515415-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639205A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515416-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639209A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515417-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639211A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515418-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639227A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515419-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639229A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515420-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639234A</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515421-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639318A</companynumb>
    <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>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515422-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639431A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515423-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639483A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515424-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639516A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515425-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639519A</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515426-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639523A</companynumb>
    <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515427-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639536A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515428-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639542A</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOCALCINNS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515429-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639552A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515430-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639558A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515431-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639566A</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515432-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639574A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515433-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639581A</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515434-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639582A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>261</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515435-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639707A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515436-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639709A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515437-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639714A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515438-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639734A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515439-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639743A</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>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515440-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639802A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515441-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640050A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515442-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640051A</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>141.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070206</drugenddate>
        <drugtreatmentduration>23</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>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG IN THE MORNING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515443-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640052A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515444-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640066A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515445-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640077A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515446-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640119A</companynumb>
    <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>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515447-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640138A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515448-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640139A</companynumb>
    <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>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515449-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640252A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070218</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515450-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640264A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + MAGNESIUM SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515451-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640273A</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILACOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515452-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640275A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515453-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640282A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515454-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640288A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515455-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640425A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>7876V42</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515456-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640442A</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>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515457-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640457A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515458-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640480A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515459-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640574A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERICAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515460-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640586A</companynumb>
    <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515461-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640593A</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>HUNGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515462-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640605A</companynumb>
    <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>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515463-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640615A</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>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515464-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640776A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE DECREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515465-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640782A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELMALEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515466-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640804A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515467-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640969A</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>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515468-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641008A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515469-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641011A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515470-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641020A</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515471-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641135A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515472-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641137A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515473-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641142A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR HYPERTROPHY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515474-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641153A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070225</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515475-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641175A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515476-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641180A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515477-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641181A</companynumb>
    <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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515478-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641185A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515479-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641190A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515480-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641223A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515481-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641227A</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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515482-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641363A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515483-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641497A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515484-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641499A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515485-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641501A</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515486-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641522A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515487-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641569A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515488-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641619A</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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515489-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641886A</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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP6013</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070215</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515490-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641887A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515491-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641889A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515492-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641903A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515493-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641907A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515494-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641984A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515495-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642087A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515496-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642097A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515497-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642104A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515498-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642105A</companynumb>
    <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>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515499-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642112A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515500-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515501-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642150A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515502-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642167A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515503-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642194A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515504-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642222A</companynumb>
    <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 ORTHOSTATIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515505-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642324A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515506-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642462A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515507-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642602A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515508-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642608A</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>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515509-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642833A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515510-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643037A</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>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515511-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643047A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515512-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643051A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLACK HAIRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515513-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643065A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515514-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643077A</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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515515-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643235A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515516-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643247A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515517-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643252A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515518-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643253A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515519-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643281A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515520-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643538A</companynumb>
    <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515521-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643540A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP4151</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515522-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643560A</companynumb>
    <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 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515523-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643562A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515524-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643671A</companynumb>
    <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 INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515525-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643691A</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>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515526-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643713A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR FLUID RETENTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515527-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643716A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515528-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643718A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515529-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643723A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515530-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643916A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515531-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643933A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515532-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644084A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515533-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644089A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515534-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644092A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC VENTRICULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515535-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644115A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515536-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644278A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515537-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515538-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644368A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515539-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644371A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515540-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644622A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515541-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644627A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515542-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644636A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515543-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644652A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515544-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644818A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515545-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644826A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515546-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644831A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515547-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645018A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515548-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645025A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515549-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645034A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515550-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645239A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515551-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645246A</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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40U UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.125U UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5U UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515552-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645386A</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>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BUNDLE BRANCH BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515553-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645610A</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515554-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645779A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515555-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645798A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515556-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645971A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515557-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645976A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515558-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646026A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515559-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654249A</companynumb>
    <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515560-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654283A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515561-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654301A</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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515562-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654392A</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070603</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515563-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654402A</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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515564-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654419A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIOXIDANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515565-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654426A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LENTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515566-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654427A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515567-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654430A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515568-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654436A</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515569-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654443A</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>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>18.75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515570-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654447A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>2866V40</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515571-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654480A</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>104.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515572-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654609A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515573-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654868A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515574-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515575-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655054A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515576-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655291A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515577-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655293A</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>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515578-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655300A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>5423Z41</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE INJECTIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515579-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655876A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515580-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656590A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515581-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656599A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515582-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656609A</companynumb>
    <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515583-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656629A</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515584-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656709A</companynumb>
    <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515585-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656939A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515586-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656947A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515587-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656948A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515588-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656949A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515589-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657182A</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515590-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657239A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515591-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658239A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515592-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658255A</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>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515593-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658929A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515594-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658948A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515595-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658964A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515596-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658967A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515597-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658968A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515598-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659219A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515599-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659697A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>9716V42</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515600-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659950A</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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>2127Z40</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515601-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659971A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515602-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659999A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUS PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515603-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660228A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515604-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660252A</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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515605-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660317A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515606-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660341A</companynumb>
    <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515607-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660343A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515608-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660348A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515609-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661008A</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515610-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661073A</companynumb>
    <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>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515611-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661307A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515612-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661436A</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515613-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661446A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515614-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661907A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515615-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662187A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515616-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662226A</companynumb>
    <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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515617-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662250A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515618-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662492A</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>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515619-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662515A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515620-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662517A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515621-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662519A</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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515622-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662808A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>DID NOT HAVE</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515623-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662815A</companynumb>
    <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>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515624-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662978A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515625-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663320A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515626-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663348A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515627-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663682A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515628-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663695A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MSM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515629-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663847A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515630-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664013A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515631-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664014A</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515632-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664303A</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515633-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664315A</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515634-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664331A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515635-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664569A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA CAROTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPPER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515636-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664598A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515637-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664848A</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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515638-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665255A</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-LYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON INFUSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515639-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665256A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515640-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665267A</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>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515641-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665365A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515642-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665372A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>X1507</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515643-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665395A</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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515644-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665406A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515645-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665788A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515646-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665811A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515647-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665815A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MGK TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515648-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665905A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515649-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666066A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515650-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666372A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515651-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666519A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515652-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666536A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>ST09599</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515653-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666539A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515654-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666771A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515655-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667088A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>.125MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515656-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667369A</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>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515657-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667374A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515658-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667652A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515659-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667670A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515660-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667888A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515661-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667907A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515662-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667947A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515663-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668114A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515664-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668164A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515665-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668377A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515666-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668380A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>18.75MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515667-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668389A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515668-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668647A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>6ZP1684</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515669-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668940A</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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515670-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669189A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515671-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669222A</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOEXIPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515672-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669526A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515673-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669792A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515674-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669814A</companynumb>
    <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>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515675-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669825A</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>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EICOSAPENTAENOIC ACID + DOCOSAHEXANOIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515676-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670225A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515677-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671277A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515678-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671278A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515679-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671291A</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>134.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</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>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515680-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671301A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515681-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673139A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515682-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673447A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515683-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673912A</companynumb>
    <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515684-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674737A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>1X7408</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515685-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676049A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURNAL DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515686-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676074A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>PHARMACY BOT</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515687-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676127A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515688-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676134A</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515689-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676645A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515690-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676977A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>NOT AVAIL</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>LABEL COVERI</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515691-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677003A</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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515692-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677019A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>39334</drugbatchnumb>
        <drugauthorizationnumb>20297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515693-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677030A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515694-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677071A</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515695-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677076A</companynumb>
    <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>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515696-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677386A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>18.75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515697-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677740A</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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515698-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677745A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515699-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677746A</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>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515700-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677785A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515701-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677846A</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>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugbatchnumb>70227</drugbatchnumb>
        <drugdosagetext>2.5G PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515702-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678100A</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515703-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678431A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515704-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678448A</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINIDINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515705-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678451A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>261</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515706-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678455A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNACCESSIBLE</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>261</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNACCESSIBLE</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515707-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678883A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515708-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679192A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515709-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679247A</companynumb>
    <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 FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515710-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679708A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515711-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679709A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515712-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679713A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515713-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680134A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515714-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680165A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515715-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680905A</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515716-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681257A</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 INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515717-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681844A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515718-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681868A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515719-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682116A</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>3.125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515720-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682475A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515721-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682529A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515722-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SP-2007-03827</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG  THERAPEUTICS</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugdosagetext>FOR 6 MONTHS</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515723-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008384-07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENCYCLIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PHYSICIAN FEELS THE PATIENT WAS ON UNKNOWN AMOUNT OF PCP, THOUGH UNCONFIRMED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515724-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008519-07</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>PATIENT GIVEN 4 MG THEN 2 HOURS LATER ANOTHER 4 MG.</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN DOSAGE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NALTREXONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515725-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14504</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515726-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515727-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US10676</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>65.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515728-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US08414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>60 TO 90MG  Q2MOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>10MG ALTERNATE DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>200MCG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>175 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5MG QID ON MONDAY</drugdosagetext>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN-SALMON</medicinalproduct>
        <drugdosagetext>200 U/ML TO 50 U/ML QOD</drugdosagetext>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DATRIUM</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515729-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE02626</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETAL RETARD</medicinalproduct>
        <drugauthorizationnumb>20234</drugauthorizationnumb>
        <drugdosagetext>1-0-1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL CONVULSIONS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETAL RETARD</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>2-2-2 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515730-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CA12563</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MASTOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515731-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007AR17679</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515732-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007TW16999</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</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>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/Q4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>511</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONEFOS</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515733-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007SE18500</companynumb>
    <primarysource>
      <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>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2-3 TIMES/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515734-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14635</companynumb>
    <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>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>011793</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515735-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02559</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515736-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18497</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515737-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA                                 /IRE/</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALIVIT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515738-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007FR18614</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>180 MG/YEAR</drugdosagetext>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>240 MG/YEAR</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515739-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT18634</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENIPUNCTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515740-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03697</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515741-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02550</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515742-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515743-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14568</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515744-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14472</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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugauthorizationnumb>011793</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515745-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.083</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>884</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugindication>SPINAL CORD COMPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>54720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515746-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03729</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, Q3MO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIRHEUMATIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515747-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17822</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugdosagetext>0.05 UG/KG/MIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515748-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03146</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515749-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA02167</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515750-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IE17475</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>3 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515751-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03255</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50MG</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>TONSILLECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>160MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>2MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>3MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515752-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11568</companynumb>
    <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>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515753-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14613</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>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515754-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CA13117</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515755-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03686</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>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITOMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</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>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060517</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LEUKOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515756-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>10 MG/ 160 MG, UNK</drugdosagetext>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515757-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12182</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515758-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2007AU01847</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON DIOXIDE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12 - 500MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030325</drugenddate>
        <drugtreatmentduration>3145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515759-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02534</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515760-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP15061</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515761-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09361</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>75643</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515762-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE394122JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515763-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H01051807</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAPILLARY FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISALIN</medicinalproduct>
        <drugdosagetext>1500 MG/FREQUENCY NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515764-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE450027JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515765-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09286</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENAHEXAL COMP (NGX)(ENALAPRIL, HYDROCHLOROTHIAZIDE) TABLET, 10/25MG</medicinalproduct>
        <drugauthorizationnumb>76116</drugauthorizationnumb>
        <drugdosagetext>8 X 10/25 MG AT ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515766-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP18753</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>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE COMPARATOR COMP-AML+</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE COMPARATOR COMP-AML+</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN, AMLODIPINE</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515767-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007SI03702</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515768-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE18753</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515769-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09364</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515770-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09363</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>125 MG, QD,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515771-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-200716759GDS</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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOBAR PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 5 MG  UNIT DOSE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515772-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713796BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515773-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200712503BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>AS USED: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515774-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>IMPLANTABLE DEFIBRILLATOR INSERTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515775-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007PL09274</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY CASTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugauthorizationnumb>74024</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC (NGX)(DICLOFENAC) UNKNOWN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AULIN ^MEDICOM^(NIMESULIDE)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE (RAMIPRIL) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON (CHLORTALIDONE) UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515776-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09231</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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>83101</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (NGX)(PARACETAMOL) UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515777-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09093</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYLPENICILLIN (NGX)(PHENOXYMETHYLPENICILLIN (= PENICILLIN V)</medicinalproduct>
        <drugauthorizationnumb>64071</drugauthorizationnumb>
        <drugindication>CELLULITIS</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOXACILLIN BENZATHINE</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515778-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007PL09315</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>20</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSPEN (NGX)(PHENOXYMETHYLPENICILLIN BENZATHINE) UNKNOWN, 400000/5IU/ML</medicinalproduct>
        <drugbatchnumb>143571</drugbatchnumb>
        <drugauthorizationnumb>64071</drugauthorizationnumb>
        <drugdosagetext>1200000 IU, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS STREPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515779-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070801817</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>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOSTRIDIUM BUTYRICUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANDOSPIRONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIVERINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515780-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20071101370</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515781-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20071103507</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET AGGREGATION DECREASED</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>5515782-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102259</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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515783-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-JNJFOC-20071102618</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</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>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515784-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102668</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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515785-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070804682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515786-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070202973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515787-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071006470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LO/OVRAL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515788-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061203572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515789-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061106137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515790-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103512</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 FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515791-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103513</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515792-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103516</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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515793-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004832</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>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE                                              (PREDNISOLONE) </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515794-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004625</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, ORAL; 2 MG, ORAL; 2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, ORAL; 2 MG, ORAL; 2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1 MG, ORAL; 2 MG, ORAL; 2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060904</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, QOD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515795-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
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    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE200711002256</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515796-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
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    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR200711001125</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515797-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710000024</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA FINE GRANULE 1%</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515798-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU200711000324</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>6 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>9 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBARBITAL SODIUM</medicinalproduct>
        <drugdosagetext>400 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>37.5 MG, LONG-ACTING INJECTABLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>8 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG, QOD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>300 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINPOCETINE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515799-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004095</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>PER ORAL NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR                  (SULFAMETHOXAZOLE, TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON                    (ALENDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE                                          (TICLOPIDINE HYDROC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515800-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP001048</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515801-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713326BWH</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515802-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-200713994GDS</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515803-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002570</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL; 0.8 MG/KG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL; 0.8 MG/KG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515804-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, ORAL; 3 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, ORAL; 3 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE                                                    TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN                                     (LOXOPROFEN) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVEN EP                               (ENZYMES NOS) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S                           (LEVOGLUTAMIDE, SODIUM GUALENATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS                                        (KETOPROFEN) TAPE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515805-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001853</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN, REGULAR            (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITROL                  (ERGOCALCIFEROL, RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE/SALICYLIC ACID OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N        (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515806-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-12257</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.8 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515807-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713372BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515808-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-200716827GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515809-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP000768</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO, 150 MG/M2; QD; PO, 150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO, 150 MG/M2; QD; PO, 150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG/M2; QD; PO, 150 MG/M2; QD; PO, 150 MG/M2; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515810-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-008344-07</companynumb>
    <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugdosagetext>4MG INITIAL DOSE IN OFFICE</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANBARS</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515811-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-WYE-H00966007</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANGOREX</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ADIRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIKET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515812-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022220</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGATRON                        (PEGYLATED INTERFERON ALFA-2B W/RIBAVI</medicinalproduct>
        <drugdosagetext>SC, PO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGATRON                        (PEGYLATED INTERFERON ALFA-2B W/RIBAVI</medicinalproduct>
        <drugdosagetext>SC, PO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515813-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021401</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugbatchnumb>118117204</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>110 MG; QD, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugbatchnumb>118117204</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>110 MG; QD, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugbatchnumb>118117204</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>110 MG; QD, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugbatchnumb>118117204</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>110 MG; QD, 300 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>8 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515814-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-267977</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>TT60192</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515815-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268914</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515816-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268765</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>SP51439</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>25 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>25 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANIRACETAM</medicinalproduct>
        <drugdosagetext>.3 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515817-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AE-NOVOPROD-268108</companynumb>
    <primarysource>
      <reportercountry>UNITED ARAB EMIRATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1700 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE TAB</medicinalproduct>
        <drugdosagetext>LOCAL INJECTIONS THREE TIMES PER YEAR</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515818-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-268660</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515819-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004977</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>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU (HERBAL EXTRACT NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515820-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-269211</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID NOVOLET</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugdosagetext>24 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID NOVOLET</medicinalproduct>
        <drugbatchnumb>TP50684</drugbatchnumb>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>24 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID NOVOLET</medicinalproduct>
        <drugauthorizationnumb>019938</drugauthorizationnumb>
        <drugdosagetext>24 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515821-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13976410</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>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515822-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13798798</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>TOTAL DOSE = 30 GY 10 SESSIONS IN RIGHT ILIAC.</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070514</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVREDOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515823-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE041017JUL07</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE THOUGHTS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515824-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE897210AUG05</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>150MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050723</drugenddate>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515825-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-13977632</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHRENIC NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILET</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515826-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13920905</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugauthorizationnumb>50679</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugdosagetext>700 MG 03-SEP-2007 TO 03-SEP-2007. THERAPY DURATION 22 DAYS.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugdosagetext>90 MG; IVDRI ON 03-SEP-2007 TO 03-SEP-2007. THERAPY DURATION 22 DAYS.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>ONE DOSAGE FORM = 75 UG FROM 20-AUG-27-AUG AND 17-SEP-2007 TO 19-SEP-2007.</drugdosagetext>
        <drugindication>NEUTROPHIL COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>ONE DOSAGE FORM = 75 UG FROM 20-AUG-27-AUG AND 17-SEP-2007 TO 19-SEP-2007.</drugdosagetext>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515827-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13977970</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515828-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13959929</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515829-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13978945</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515830-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004959</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>51.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>17.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC               (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515831-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE417026JUL04</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515832-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE424726JUL04</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515833-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE608110APR03</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>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515834-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18305</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEMOLINE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515835-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>040517</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515836-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14628</companynumb>
    <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</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>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515837-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03712</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG/24 HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515838-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03698</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</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>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515839-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004947</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>44.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS           CAPSULES</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL            (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAC                (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA              (FERROUS CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515840-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP000119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, D, ORAL, 3 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, D, ORAL, 3 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL                 (BUCILLAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN            SLOW RELEASE CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA                       (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYLOTENSIN                   (NITRENDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS         (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515841-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004980</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>43.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS                CAPSULES</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN                   (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515842-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugauthorizationnumb>40517</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugauthorizationnumb>075983</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515843-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25949</companynumb>
    <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>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515844-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022932</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515845-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI010391</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>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>6021/28 YTRACIS [Y-90 ZEVALIN]</drugbatchnumb>
        <drugdosagetext>924 MBQ; 1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>42014A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515846-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI000059</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>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>Y-90 ZEVALIN</drugbatchnumb>
        <drugdosagetext>0.4 MCI/KG; 1X; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515847-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007PL09276</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDACIN                            (CEFTRIAXONE) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>65204</drugauthorizationnumb>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOTRAKSON                                    (CEFTRIAXONE SODIUM)</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515848-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09366</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE                                                      (CLONID</medicinalproduct>
        <drugauthorizationnumb>70886</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOURETTE'S DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515849-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BRISTOL-MYERS SQUIBB COMPANY-13980396</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHOMOCYSTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515850-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13979398</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>23JUL07 TO 30JUL07-6MG WAS GIVEN AND INCREASED TO 12MG FROM 31-JUL TO 01-OCT-2007</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515851-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01139507</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugauthorizationnumb>007935</drugauthorizationnumb>
        <drugdosagetext>DOSE AND FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugdosagetext>DOSE AND FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515852-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE445027JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515853-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00598107</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugdosagetext>800 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070929</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG TOTAL DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515854-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13976469</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>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCARBAMIDE</medicinalproduct>
        <drugauthorizationnumb>16295</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515855-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13980115</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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS</medicinalproduct>
        <drugauthorizationnumb>21061</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KANAMYCIN</medicinalproduct>
        <drugauthorizationnumb>061901</drugauthorizationnumb>
        <drugdosagetext>2.25 MG/WEEK INTO 3 DIVIDED DOSES.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MYCOBACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515856-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13960513</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515857-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13980248</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>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugauthorizationnumb>12142</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>IT WAS ALSO GIVEN ON 21SEP07-21SEP07,23SEP07-23SEP07</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515858-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-JNJFOC-20071004000</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</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>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515859-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071101628</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515860-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20060906592</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515861-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20071102600</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515862-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04933</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
        <drugauthorizationnumb>17534</drugauthorizationnumb>
        <drugdosagetext>12.5 G ACETYLSALICYLIC ACID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515863-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021240</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>4 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515864-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019852</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.21</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOGENETIC ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR SUCKING REFLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515865-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007000719</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>(150 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515866-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30815_2007</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>(5 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE                                  (CLEXANE-ENOXAPARIN SODIUM)</medicinalproduct>
        <drugdosagetext>(80 MG QD SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>(25 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>(2 ML TID 0.5% SOLUTION NASAL)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LARYNGEAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>(400 MG BID INTRAVENOUS (NOT OTHERWISE SPECIFIED))</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>(500 UG TID)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515867-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002072</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB                                                     (ERLOTIN</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>(150 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB                                           (INJECTION FOR I</medicinalproduct>
        <drugdosagetext>(670 MG, Q2W), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHOLE BLOOD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515868-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022234</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.2</patientweight>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515869-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-02755</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>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL                  (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE                           (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515870-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-04937</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR</medicinalproduct>
        <drugauthorizationnumb>21288</drugauthorizationnumb>
        <drugdosagetext>11.25 MG, Q 3 MONTHS, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515871-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023060</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515872-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03609</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>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515873-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI011378</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICTONORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515874-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03632</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515875-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018201</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515876-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03680</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515877-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00663</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL PLUS                         (INDAPAMIDE, PERINDOPRIL ERBUMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL                   (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA                  (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515878-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03514</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG,</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASORETIC (HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASIL (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515879-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03555</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>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515880-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18285</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG,BID,ORAL, 62.5 MG,BID;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG,BID,ORAL, 62.5 MG,BID;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN                                       (METFORMIN HYDROCHLORI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515881-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW23693</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>
      <patientweight>86.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>734</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>TAPER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515882-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007PL09293</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR RESISTANCE SYSTEMIC DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugauthorizationnumb>71423</drugauthorizationnumb>
        <drugdosagetext>70 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515883-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007IT09326</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>80399</drugauthorizationnumb>
        <drugdosagetext>4 CYCLES, 1 CYCLE EVERY 28 DAYS, 60 MG/M2 ON DAY 1 EVERY 28 DAYS, 2 CYCLES</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>4 CYCLES, 1 CYCLE  EVERY 28 DAYS, 120 MG/M2, DAY 1-3 EVERY 28 DAYS, 2 CYCLES</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG, DAILY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRRADIATION(NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
        <drugdosagetext>TOTAL 36 GY IN 2 GY DAILY FRACTIONS</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515884-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071101507</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>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515885-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20070806528</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515886-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070901955</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVED 3 DOSINGS ON UNKNOWN DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515887-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007JP09322</companynumb>
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      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>5515888-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORC VISION BLUE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIGNOCAINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL OPTH 2.5%</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515889-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26031</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENCOLATECYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPC VISION BLUE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORBIPROFEN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL OPTH 2.5 %</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDROCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-HYDRAZIDE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>5515890-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
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  <safetyreport>
    <safetyreportid>5515891-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <companynumb>FR-AVENTIS-200713527FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUITEL                            /00810601/</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPECYCLAL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>5515892-2</safetyreportid>
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      <reportercountry>JAPAN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
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        <drugindication>DIABETES MELLITUS</drugindication>
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        <drugenddate>20071002</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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        <drugenddate>20070904</drugenddate>
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  <safetyreport>
    <safetyreportid>5515893-4</safetyreportid>
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      <reportercountry>SWEDEN</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
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        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
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        <drugstartdate>20060614</drugstartdate>
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        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
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      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
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        <reactionmeddrapt>FALL</reactionmeddrapt>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18208</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515896-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18148</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY CIRRHOSIS PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515897-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18262</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>27.2158</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515898-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004679</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76241</drugauthorizationnumb>
        <drugdosagetext>15 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYL PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515899-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004678</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>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>77033</drugauthorizationnumb>
        <drugdosagetext>10 MG;QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515900-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSU-2007-00836</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, QD), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515901-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101558</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>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515902-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSJ-2007-02706</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON (GLICLAZIDE) (TABLET) (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S (LEVOTHYROXINE SODIUM) (TABLET) (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL (ISOSORBIDE MONONITRATE) (TABLET) (ISOSORBIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN (ACETYLSALICYLIC ACID) (TABLET) (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HYDROCHLORIDE) (TABLET) (BENIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION (TRIAZOLAM) (TABLET) (TRIAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B (LACTOBACILLUS BIFIDUS, LYOPHILIZED) (LACTOBACILLUS BIFIDUS, LYO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANCOLON (MEPENZOLATE BROMIDE) (TABLET) (MEPENZOLATE BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO (TABLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515903-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200710626BFR</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>QUADRIPLEGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECONAZOLE NITRATE</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDUCTYL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugindication>GASTROINTESTINAL MOTILITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515904-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200716795GDS</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB OR PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON (ONDANSETRON HCL)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515905-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071102620</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>BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515906-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-JNJFOC-20071102130</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</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>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>5 MG/KG AT WEEKS 1, 2 AND 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515907-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11977</companynumb>
    <primarysource>
      <reportercountry>EGYPT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>120 U/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515908-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0590349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE LOZENGE</medicinalproduct>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugdosagetext>1LOZ IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>5G1504</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugdosagetext>21MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>5C1507</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugdosagetext>14MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>2EC05053</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515909-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200710933BVD</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515910-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-200715680GDS</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>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugbatchnumb>CT2019/15</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 600 ?G</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515911-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007PV000044</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPOCYT</medicinalproduct>
        <drugauthorizationnumb>21041</drugauthorizationnumb>
        <drugdosagetext>50 MG; INTH</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515912-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-200611112BFR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
        <drugtreatmentduration>15</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>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515913-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-200710734BNE</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>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515914-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25791</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>DENGUE FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDECORT</medicinalproduct>
        <drugauthorizationnumb>20746</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCLORITIAZIDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515915-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25781</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>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515916-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25801</companynumb>
    <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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515917-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW19230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515918-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW26830</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>98.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061122</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515919-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-ABBOTT-07P-034-0419726-00</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV WASTING SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</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>20070130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOPUTINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPHY (CHCLOPHOSPHAMIDE VYNCRISTINE, PREDNISONE)</medicinalproduct>
        <drugdosagetext>3RD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515920-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008797</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0708005</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHELCAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOSPRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515921-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004676</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>75690</drugauthorizationnumb>
        <drugdosagetext>20 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515922-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX002667</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515923-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25829</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>97.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515924-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007IT18634</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENIPUNCTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515925-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14378</companynumb>
    <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515926-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03241</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515927-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13978002</companynumb>
    <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>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugauthorizationnumb>021061</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515928-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18803</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOREDOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugdosagetext>2.5 ML, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugdosagetext>5 ML, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021285</drugauthorizationnumb>
        <drugdosagetext>10 ML, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515929-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007VE18801</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>3 CC, Q8H</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515930-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007FR18503</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
    </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>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUTOX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>100MG/10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>250/25 MG 1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>10 UNK, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HCL</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515931-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14487</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>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515932-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07H-008-0313364-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISUPREL INJ</medicinalproduct>
        <drugauthorizationnumb>10515</drugauthorizationnumb>
        <drugdosagetext>600 MCG, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515933-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00870</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515934-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009529</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>77362</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515935-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2007FR02560</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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515936-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03754</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETAL RETARD</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETAL RETARD</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515937-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-239075</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515938-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-514227</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515939-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018319</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN HYDATIDIFORM MOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DILATION AND CURETTAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515940-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP018261</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugindication>BRONCHIOLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515941-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18047</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTATIC CARCINOMA OF THE BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL, 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL, 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515942-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK-6037914</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>75568</drugauthorizationnumb>
        <drugdosagetext>50 MG; TWICE A DAY</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515943-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-17334</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JODTHYROX (POTASSIUM IODIDE, LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515944-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-467348</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>54.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515945-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009518</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHIC HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>75568</drugauthorizationnumb>
        <drugdosagetext>DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980504</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHOCLONE OKT3</medicinalproduct>
        <drugdosagetext>5 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980506</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515946-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-489097</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICUT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOTRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPLEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515947-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515948-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP03275</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>010417</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>1/3 OF A CAPSULE 10 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515949-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01553</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26355</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROWASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMINOPHENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHLOROGLUCINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDOSE VITAMINE D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLIGOSOL LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515950-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-529639</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY REPORTED AS CYCLIC.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515951-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-529637</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENERVA</medicinalproduct>
        <drugauthorizationnumb>013263</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515952-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-432383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY, THEN ADD 40 MG MORE EVERY OTHER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515953-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-509464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</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>20010412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515954-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</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>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</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>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>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPOUSAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIOLENCE-RELATED SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</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>5515955-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008780</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0707025</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0708005</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMDURA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN                               /UNK/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOOTROPIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTKLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515956-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMULEN 1/35-28</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515957-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0496387A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>3I29</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515958-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625510A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515959-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625511A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515960-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625527A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515961-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625530A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515962-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625535A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO FOOD ADDITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPARTAME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515963-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625554A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515964-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625558A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515965-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625764A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515966-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625789A</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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515967-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625793A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515968-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625797A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515969-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625803A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515970-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625965A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061009</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515971-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625973A</companynumb>
    <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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515972-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625975A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515973-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625985A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515974-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625993A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515975-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0625997A</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515976-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626000A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515977-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626003A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515978-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626012A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515979-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626096A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515980-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626102A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626119A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515982-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626262A</companynumb>
    <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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515983-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626265A</companynumb>
    <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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515984-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626269A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626298A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-17158</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515987-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626299A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626314A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626317A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626320A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626497A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515992-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626508A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626521A</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>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626657A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626707A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626711A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061107</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626817A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626818A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061120</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5515999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626819A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516000-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626838A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516001-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626841A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516002-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626842A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516003-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626852A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516004-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0626861A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5L19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516005-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627006A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516006-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627189A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516007-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627199A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516008-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627209A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516009-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627246A</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>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516010-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627247A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516011-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627255A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516012-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627405A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516013-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627422A</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>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516014-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627424A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516015-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627435A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516016-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627438A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516017-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627447A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516018-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627449A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516019-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627452A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516020-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627456A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516021-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627598A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516022-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627615A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516023-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627631A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516024-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627632A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H22</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBACCO</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516025-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627762A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516026-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627777A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516027-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627781A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516028-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627786A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516029-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627796A</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516030-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627799A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516031-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009460</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>75568</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516032-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627806A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6114</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBELIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516033-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627880A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516034-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627902A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516035-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627904A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516036-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627910A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516037-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627914A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516038-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627915A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>GL897</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516039-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0627918A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4B16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516040-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628040A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516041-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516042-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628048A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516043-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628095A</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5B21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516044-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628096A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516045-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628222A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516046-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628245A</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516047-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628263A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516048-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-16627</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516049-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628399A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516050-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628418A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516051-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628599A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516052-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628600A</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516053-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628629A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516054-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628635A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516055-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628654A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516056-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628656A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516057-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628659A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516058-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628660A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516059-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516060-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628663A</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516061-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628889A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516062-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628895A</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>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516063-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628899A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516064-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516065-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628937A</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>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516066-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628945A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516067-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628949A</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516068-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0628957A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516069-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629355A</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>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516070-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629362A</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>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516071-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629369A</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>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516072-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629401A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516073-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629408A</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>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516074-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629409A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516075-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629412A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061128</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516076-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629634A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516077-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629651A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516078-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629661A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516079-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629877A</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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516080-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629880A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516081-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629881A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516082-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0629899A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516083-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630151A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516084-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630158A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516085-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630180A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516086-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630198A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516087-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630363A</companynumb>
    <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>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516088-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630374A</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>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516089-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630380A</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>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516090-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630382A</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516091-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630387A</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>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061127</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516092-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630398A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>3D21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>3B17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516093-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630580A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516094-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630591A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516095-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630592A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516096-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630754A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516097-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630760A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516098-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630869A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516099-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630872A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516100-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630874A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516101-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630878A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516102-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0630886A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516103-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631077A</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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516104-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631084A</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>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516105-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631102A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516106-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631253A</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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516107-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631262A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516108-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516109-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631282A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516110-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631284A</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516111-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631294A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516112-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631393A</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516113-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631421A</companynumb>
    <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>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516114-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631544A</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516115-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631569A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516116-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631586A</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061213</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516117-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631706A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5G11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516118-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631707A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516119-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631708A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4A26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516120-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631871A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516121-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631873A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516122-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0631904A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516123-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632059A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516124-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632062A</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4H23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516125-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632073A</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>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5B21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516126-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632080A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516127-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632085A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516128-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632238A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516129-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632240A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516130-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632241A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516131-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632250A</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>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516132-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632262A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516133-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632266A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516134-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632273A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516135-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632275A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516136-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632408A</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>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516137-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632411A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5C28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061220</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516138-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632430A</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>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516139-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632437A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516140-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516141-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632669A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516142-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632670A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516143-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632672A</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>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516144-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632720A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516145-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632779A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516146-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632807A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516147-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0632840A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061229</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516148-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633096A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516149-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633097A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516150-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633099A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516151-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633101A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516152-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633107A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516153-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633109A</companynumb>
    <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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516154-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633117A</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516155-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633127A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516156-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633128A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516157-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633133A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516158-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633137A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>2MG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516159-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633138A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516160-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-458427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSING REGIMEN REPORTED AS: QD DIVIDED DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>DOSING REGIMEN REPORTED AS: BID.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516161-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-451852</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516162-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-485880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENAMEL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESONIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516163-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-367621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHONOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ENTERITIS INFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>ENTERITIS INFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>ON 18 APR 2001, THERAPY REPORTED AS TWICE DAILY.</drugdosagetext>
        <drugindication>ENTERITIS INFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
        <drugindication>EPIDIDYMITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>BY TAPER.</drugdosagetext>
        <drugindication>VESTIBULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>ON 18 APR 2001, THERAPY REPORTED AS: AS NEEDED.</drugdosagetext>
        <drugindication>VESTIBULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516164-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-502322</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIVASCULAR DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>PATIENT REPORTED ON 180 MCG PER WEEK.  NO DOSING INFORMATION PROVIDED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^ALOH^</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^TRISIL^</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516165-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-485903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</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>FLIGHT OF IDEAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>STRENGTH NOTED AS 20 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>INDICATION FOR USE REPORTED AS SKIN.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM</medicinalproduct>
        <drugdosagetext>REPORTED AS ORTHO NOVUM 777</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLISTEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WESTCORT OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CHEILITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516166-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2007-18308</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDARTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL ; 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID, ORAL ; 62.5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIXOL (ZUCLOPENTHIXOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516167-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-506951</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>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516168-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-488800</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>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070128</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070128</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516169-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-530070</companynumb>
    <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>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516170-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633157A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516171-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633679A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516172-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633687A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516173-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633693A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516174-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633700A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516175-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633704A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516176-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633714A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516177-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633716A</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>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516178-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633720A</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>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516179-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633726A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516180-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633729A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516181-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633731A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516182-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0633732A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516183-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634039A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516184-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634044A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516185-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634045A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516186-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634058A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>3I29</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516187-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634065A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516188-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634074A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516189-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634078A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4H23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516190-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634093A</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516191-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634094A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516192-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634097A</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>61.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6128</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516193-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634101A</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>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516194-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634385A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516195-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634399A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516196-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634410A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516197-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634411A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516198-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634424A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516199-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634435A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516200-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634450A</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>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516201-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634453A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516202-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634632A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516203-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634639A</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>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516204-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634653A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516205-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634661A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCODAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516206-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634669A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516207-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634676A</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>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516208-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634684A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516209-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634687A</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516210-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634694A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516211-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634698A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516212-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634701A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516213-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634703A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516214-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634704A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516215-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634712A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516216-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634716A</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>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516217-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634840A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516218-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634846A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516219-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634855A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516220-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634856A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>4L06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516221-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634860A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516222-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634864A</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>DEVICE INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516223-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634875A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516224-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634883A</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>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5E16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516225-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634900A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516226-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0634915A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516227-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635084A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516228-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635085A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070107</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516229-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635089A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516230-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635104A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516231-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635109A</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>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516232-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635112A</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>APPLICATION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516233-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635123A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516234-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635125A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516235-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635132A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516236-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635134A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516237-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635153A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516238-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635157A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516239-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635285A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516240-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635286A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516241-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635293A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516242-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635294A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5G25</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516243-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635299A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516244-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635302A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516245-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635306A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516246-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635307A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516247-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635312A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G0999</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516248-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635314A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516249-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635325A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516250-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635329A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516251-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635339A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516252-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635445A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516253-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635455A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516254-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635468A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516255-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635477A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516256-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635482A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516257-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635500A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516258-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635501A</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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516259-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635626A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516260-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635627A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516261-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635629A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516262-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635636A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516263-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635648A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516264-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635650A</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>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUATE NTS 21MG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070114</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516265-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635657A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516266-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635780A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516267-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635790A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516268-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635791A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516269-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635797A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516270-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635804A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516271-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635831A</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>2L09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516272-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635848A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516273-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635851A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516274-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635919A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516275-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635932A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516276-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635950A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516277-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0635966A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516278-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636050A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516279-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636081A</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516280-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636233A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516281-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636244A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516282-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636283A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516283-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636284A</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>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516284-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636289A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516285-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636429A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516286-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636449A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516287-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636452A</companynumb>
    <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516288-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636453A</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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516289-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636454A</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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516290-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636465A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516291-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636478A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516292-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516293-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636483A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516294-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636491A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516295-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636499A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516296-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636627A</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516297-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636630A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516298-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636643A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516299-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636661A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516300-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636670A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5105</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516301-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636675A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516302-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636782A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516303-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636801A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516304-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636803A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516305-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636838A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516306-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636841A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516307-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636842A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516308-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636843A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516309-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636938A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>5K0201</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516310-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636949A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUATE NTS 14MG</medicinalproduct>
        <drugdosagetext>14MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516311-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636969A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060215</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516312-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636971A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516313-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636978A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516314-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516315-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636984A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516316-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0636995A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516317-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637014A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516318-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637118A</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>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516319-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637130A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516320-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637139A</companynumb>
    <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>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516321-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637142A</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>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516322-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637150A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516323-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637290A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>GL905</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516324-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637292A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516325-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637309A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516326-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637337A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516327-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637357A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516328-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637365A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516329-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637366A</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516330-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637527A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516331-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637540A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516332-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637541A</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516333-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637560A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516334-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637561A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516335-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637564A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516336-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637567A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516337-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637585A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516338-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637587A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070104</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516339-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637593A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516340-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637599A</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516341-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637600A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516342-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637612A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516343-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637735A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516344-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637755A</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070129</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516345-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637912A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516346-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637934A</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>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516347-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637939A</companynumb>
    <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516348-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637941A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516349-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637948A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516350-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0637956A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516351-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638242A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516352-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638243A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516353-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638255A</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>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>HE935</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516354-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638268A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K15</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516355-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638281A</companynumb>
    <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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516356-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638293A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516357-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638306A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516358-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638307A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516359-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638311A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516360-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638313A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516361-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638319A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516362-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638457A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070204</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516363-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638498A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516364-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638507A</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516365-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638512A</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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516366-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638534A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516367-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638537A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516368-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638654A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516369-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638684A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516370-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101785</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugdosagetext>100 UG/HR AND 75 UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516371-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102985</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>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516372-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638703A</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>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516373-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638724A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516374-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638828A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516375-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638858A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516376-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638865A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516377-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638966A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516378-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638972A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516379-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638979A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516380-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0638982A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516381-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639005A</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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516382-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639120A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516383-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639134A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516384-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639144A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516385-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639160A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516386-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639177A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516387-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639179A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516388-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639190A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516389-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639335A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0122897</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516390-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639338A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516391-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639339A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516392-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639341A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516393-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639344A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516394-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639371A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516395-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639376A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516396-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639498A</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516397-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639501A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516398-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639651A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516399-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639658A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516400-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639665A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516401-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639694A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516402-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639825A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX PSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIQUE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516403-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639826A</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>ORAL MUCOSAL ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516404-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639841A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516405-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639842A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516406-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516407-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639850A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516408-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639852A</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516409-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639863A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516410-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639864A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516411-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639876A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516412-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639954A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516413-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639955A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516414-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639976A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516415-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639980A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516416-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639992A</companynumb>
    <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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516417-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0639993A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516418-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640014A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516419-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640181A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516420-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640184A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516421-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640187A</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>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516422-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640207A</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>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516423-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640244A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516424-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640335A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516425-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640340A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516426-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640348A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516427-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640350A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516428-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640351A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516429-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640352A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516430-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640361A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516431-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640364A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5F06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516432-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640370A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516433-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640381A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516434-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640395A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516435-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640502A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516436-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640506A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516437-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640513A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516438-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640518A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516439-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640519A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516440-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640527A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516441-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640529A</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>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0625706</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516442-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640538A</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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516443-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640544A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516444-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640552A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6118</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070210</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516445-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640567A</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>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516446-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640569A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516447-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640687A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516448-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640713A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516449-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640714A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516450-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640720A</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516451-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640737A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516452-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640750A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516453-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640754A</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>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516454-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640873A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516455-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640880A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516456-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640892A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516457-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640901A</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516458-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640902A</companynumb>
    <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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516459-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0640915A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516460-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641059A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516461-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641066A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516462-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641080A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516463-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641083A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516464-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641090A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516465-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641100A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516466-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641108A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516467-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641287A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516468-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641296A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516469-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641309A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516470-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641315A</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>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516471-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641320A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYCHOTROPIC MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516472-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641336A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516473-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641341A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516474-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641431A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6108</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516475-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641438A</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516476-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641439A</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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516477-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641441A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516478-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641447A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516479-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641453A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516480-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641458A</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516481-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641462A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516482-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641466A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516483-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516484-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641648A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516485-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641653A</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516486-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641656A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG FOR ANXIETY</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516487-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641665A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516488-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641672A</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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516489-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641675A</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516490-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641676A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516491-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641679A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070227</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516492-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641683A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516493-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641810A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516494-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641826A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516495-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641833A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516496-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641836A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516497-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641842A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516498-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641843A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516499-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641857A</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>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516500-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0641862A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516501-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642023A</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516502-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642054A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516503-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642058A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516504-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642243A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516505-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642263A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516506-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642271A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516507-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642272A</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516508-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642278A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516509-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642291A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516510-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642307A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516511-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642309A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5F06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516512-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642347A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516513-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642349A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516514-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642374A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516515-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642401A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516516-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642408A</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>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516517-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642532A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516518-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642555A</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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070309</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516519-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642556A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>5L19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516520-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642739A</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>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516521-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642750A</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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516522-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642770A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516523-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642771A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516524-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642775A</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>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516525-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642779A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516526-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642791A</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>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516527-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642800A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516528-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642803A</companynumb>
    <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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516529-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642806A</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>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516530-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642967A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516531-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642986A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6108</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516532-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642988A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516533-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642993A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516534-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0642997A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516535-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643016A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516536-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643032A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516537-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643142A</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>47.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516538-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643163A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516539-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643172A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516540-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643189A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516541-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643197A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516542-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643198A</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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516543-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643304A</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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516544-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643305A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516545-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643337A</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>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516546-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643339A</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>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070306</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516547-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643348A</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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070310</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516548-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643351A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516549-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643469A</companynumb>
    <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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516550-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516551-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643482A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516552-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643483A</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>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516553-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643731A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516554-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643745A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516555-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643770A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516556-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643781A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516557-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516558-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643849A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516559-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643859A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6KO6,6KO9</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516560-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643864A</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516561-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643867A</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>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516562-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643871A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516563-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643886A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516564-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0643892A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070319</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516565-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644017A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516566-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644018A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516567-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644025A</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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516568-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644035A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516569-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644036A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516570-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644041A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516571-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644042A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516572-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PURDUE-MAG_2007_0000601</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>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>3 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>3 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>15 GRAM, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPLAT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLON CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516573-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2002JP01244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011220</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516574-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP18275</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516575-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070904782</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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUOPERAZINE</medicinalproduct>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516576-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070901428</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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516577-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071103850</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTISOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD BANGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516578-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071103444</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516579-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070903780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516580-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516581-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GILEAD-2006-0009189</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516582-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA_2007_0029685</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, TID</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516583-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009528</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>75568</drugauthorizationnumb>
        <drugdosagetext>50 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>75568</drugauthorizationnumb>
        <drugdosagetext>50 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (FLUTICASONE PROPIONATE W/SALMETEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE (TIOTROPIUM BROMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516584-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</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>SINUSITIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516586-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516587-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516588-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071104470</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIBAX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPAREN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BFLUID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIETEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516589-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101776</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</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>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516591-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009421</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>77013</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516592-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-GBR_2007_0003421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugdosagetext>10 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516593-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009419</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugauthorizationnumb>77013</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516594-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-159365-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEASLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516595-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644053A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516596-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644057A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516597-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644061A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516598-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644062A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516599-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644199A</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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516600-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644214A</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516601-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644231A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516602-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644239A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516603-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644243A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070325</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516604-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644387A</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>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516605-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644399A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516606-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644401A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516607-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644419A</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516608-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644420A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070323</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516609-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644561A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516610-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644562A</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>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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516611-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644567A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516612-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644588A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516613-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644609A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516614-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644612A</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>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516615-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644741A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516616-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644759A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516617-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644789A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516618-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644794A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516619-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644799A</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516620-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644947A</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>ORAL MUCOSAL ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516621-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644950A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>1LOZ PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516622-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644963A</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>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516623-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644988A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516624-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644989A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516625-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0644990A</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>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516626-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645002A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516627-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645003A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516628-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645005A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070327</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516629-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070329</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645006A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516630-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011075</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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76122</drugauthorizationnumb>
        <drugdosagetext>45 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516631-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645179A</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5F27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO BISMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516632-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645183A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070326</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516633-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645187A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516634-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645350A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516635-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645352A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516636-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645374A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516637-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645504A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516638-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645513A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516639-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070403</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645546A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516640-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645701A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070325</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516641-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645722A</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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516642-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645723A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516643-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645735A</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5F27</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516644-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070404</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645738A</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>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516645-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645897A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516646-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645900A</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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>2MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>150MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.25MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18MCG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516647-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645901A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516648-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0645939A</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516649-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646325A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516650-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646326A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516651-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646327A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516652-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646328A</companynumb>
    <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516653-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646330A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516654-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646334A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516655-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646340A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516656-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646367A</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516657-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646393A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J03</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516658-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646397A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516659-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646399A</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>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516660-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646400A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516661-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646429A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516662-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646434A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5105</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516663-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646435A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516664-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646552A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070408</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516665-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646556A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0605402</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516666-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646752A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516667-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646774A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6B13</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070410</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516668-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646943A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516669-4</safetyreportid>
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    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011077</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>78183</drugauthorizationnumb>
        <drugdosagetext>250 MG; TWICE A DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG; TWICE; A DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL CO-AMOXICLAV</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516670-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646958A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516671-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646963A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516672-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0646984A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L121</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516673-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647150A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516674-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647153A</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>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516675-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647157A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516676-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647311A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516677-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647366A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070404</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516678-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647517A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516679-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647536A</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>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516680-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647540A</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>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516681-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647576A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516682-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647607A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516683-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647715A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516684-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647766A</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>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516685-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647768A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516686-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647776A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516687-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647911A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516688-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647915A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516689-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647918A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516690-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647939A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516691-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647948A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516692-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647952A</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>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516693-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0647970A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516694-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648089A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516695-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648095A</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>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516696-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648129A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516697-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648301A</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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516698-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648310A</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>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516699-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648314A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516700-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648348A</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>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY MEN'S VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516701-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648479A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516702-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648482A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516703-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070416</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516704-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648517A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516705-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648631A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516706-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648634A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070424</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516707-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648683A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516708-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648687A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516709-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648794A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516710-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648797A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516711-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648818A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516712-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648827A</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>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516713-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648835A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516714-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648842A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516715-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648847A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516716-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648986A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516717-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648987A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516718-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648988A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516719-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648989A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516720-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648990A</companynumb>
    <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516721-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648992A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516722-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0648999A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516723-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649009A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516724-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649021A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516725-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649172A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070422</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516726-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649182A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516727-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649189A</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>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516728-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649195A</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>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516729-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649212A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516730-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649232A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516731-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649239A</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>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516732-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649370A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516733-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649373A</companynumb>
    <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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516734-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649376A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516735-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649404A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516736-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649407A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516737-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649409A</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>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516738-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649434A</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516739-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649446A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C07</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516740-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649603A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516741-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649613A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516742-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649651A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516743-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649826A</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>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516744-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649831A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516745-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0649836A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516746-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650061A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516747-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650071A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516748-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650076A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516749-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650088A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516750-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650158A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516751-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650162A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516752-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650223A</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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070222</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516753-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650389A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516754-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650395A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516755-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650409A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516756-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650412A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K20,7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>9LOZ PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516757-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650545A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516758-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650554A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516759-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650581A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516760-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650585A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070509</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516761-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650598A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516762-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650731A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070505</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516763-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650734A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516764-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650767A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516765-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650785A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516766-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650787A</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070508</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516767-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650923A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516768-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650957A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516769-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650960A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516770-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0650970A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516771-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651117A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516772-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651337A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516773-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651350A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K15</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516774-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651351A</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>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K15</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516775-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651355A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516776-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651357A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516777-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651500A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516778-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651501A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516779-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651518A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516780-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651540A</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516781-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651551A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516782-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651876A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516783-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651902A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516784-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651908A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516785-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0651915A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516786-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652079A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516787-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652090A</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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516788-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652102A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516789-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652105A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516790-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652116A</companynumb>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516791-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652285A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516792-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652289A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516793-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652541A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516794-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652560A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516795-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652566A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516796-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652568A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516797-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WYE-H01052507</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>72.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516798-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE847728AUG07</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516799-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01038907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>81MG FREQUENCY NOT SPECIFIED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516800-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE309310FEB03</companynumb>
    <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516801-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-WYE-H00830107</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SICK SINUS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516802-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101414</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>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516803-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101641</companynumb>
    <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516804-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20071101850</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516805-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20071005280</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516806-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20071102458</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516807-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071003758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516808-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070803704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.09</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6JM38016</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6JM38016</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>6JM38016</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516809-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>INFUSED 4, 7 AND 9 DAYS AFTER BLOOD TRANSFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516810-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011079</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>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75976</drugauthorizationnumb>
        <drugdosagetext>1 DF; DAILY; ORAL; 1 DF; TWICE A DAY; ORAL; 1 DR; 3 TIMES A DAY; ORAL; 2000 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75976</drugauthorizationnumb>
        <drugdosagetext>1 DF; DAILY; ORAL; 1 DF; TWICE A DAY; ORAL; 1 DR; 3 TIMES A DAY; ORAL; 2000 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75976</drugauthorizationnumb>
        <drugdosagetext>1 DF; DAILY; ORAL; 1 DF; TWICE A DAY; ORAL; 1 DR; 3 TIMES A DAY; ORAL; 2000 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75976</drugauthorizationnumb>
        <drugdosagetext>1 DF; DAILY; ORAL; 1 DF; TWICE A DAY; ORAL; 1 DR; 3 TIMES A DAY; ORAL; 2000 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN-S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516811-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010910</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
        <drugauthorizationnumb>72894</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516812-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL249890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516813-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US249760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516814-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK244713</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACTYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASBURICASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN (LEDERLE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516815-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-UK251041</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516816-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071000300</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>7RMKA80702</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>7RMKA80702</drugbatchnumb>
        <drugdosagetext>6 INFUSIONS ON UNSPECIFIED DATES EVERY 7-8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516817-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200720287GDDC</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>63.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LONAFARNIB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>DOSE: 10 QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL                            /00034001/</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN WITH HYDROCODONE</medicinalproduct>
        <drugdosagetext>DOSE: 5 Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugdosagetext>DOSE: 100 TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugdosagetext>DOSE: 200 MG Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>DOSE: 60 BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCLOMETASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>DOSE: 5/500</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516818-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712970JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE: 65 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OESOPHAGEAL SQUAMOUS CELL CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL                             /01178101/</medicinalproduct>
        <drugdosagetext>DOSE: 3 MG</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>DOSE: 75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN                            /00890701/</medicinalproduct>
        <drugdosagetext>DOSE: 60 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSE: 20 MG</drugdosagetext>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516819-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK229951</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>N1288AC</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516820-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US166510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS B19 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516821-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>76M91015</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>76M91015</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>76M91015</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516822-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE556827JAN04</companynumb>
    <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>0.625MG/UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516823-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00579807</companynumb>
    <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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516824-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0423438-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE/ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516825-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200720270GDDC</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN                            /00030201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516826-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717928US</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516827-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200715888US</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021144</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>DOSE: 200 MCQ, 2 PUFFS  BETWEEN 6-8 PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>DOSE: 12 UG , CRUSH CAP + INHALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN                            /00884002/</medicinalproduct>
        <drugdosagetext>DOSE: 137 UG EACH NOSTRIL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN                             /00003901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>DOSE: 10 Q 4 HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516828-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>76M91015</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>76M91015</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516829-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010911</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
        <drugauthorizationnumb>72894</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516830-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-244781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516831-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-266961</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN NN729</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>18 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN NN729</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>15 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>16 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516832-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-245153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, Q4W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugdosagetext>20 A?G, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516833-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13980784</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugauthorizationnumb>19898</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516834-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010955</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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFIN  (TERBINAFINE)</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516835-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011021</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
        <drugauthorizationnumb>76152</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516836-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011073</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>1.28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL MUSCULOSKELETAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75480</drugauthorizationnumb>
        <drugdosagetext>20 MG; DAILY; TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516837-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-246634</companynumb>
    <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516838-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247322</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516839-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011121</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>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>78891</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516840-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011123</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>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>76071</drugauthorizationnumb>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516841-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011128</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76122</drugauthorizationnumb>
        <drugdosagetext>30 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516842-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP08764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>21588</drugauthorizationnumb>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070520</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>2100 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070517</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>150 UG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINARON</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>60 ML/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGACIN</medicinalproduct>
        <drugdosagetext>0.9 G/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516843-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES10329</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516844-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010699</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75480</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516845-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011050</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>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>74732</drugauthorizationnumb>
        <drugdosagetext>20 MG; TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516846-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011052</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>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE (TERBINAFINE)</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516847-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20071007829</companynumb>
    <primarysource>
      <reportercountry>CHINA</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>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516848-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011059</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE (TERBINAFNE)</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516849-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011072</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76671</drugauthorizationnumb>
        <drugdosagetext>50 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516850-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE452027JUL04</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516851-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200711AGG00746</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 MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>25 MCG/KG TOTAL INTRAVENOUS BOLUS, (INTRAVENOUS DRIP)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CARDIAC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>25 MCG/KG TOTAL INTRAVENOUS BOLUS, (INTRAVENOUS DRIP)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CARDIAC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516852-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516853-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US242295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516854-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-US251756</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>2MG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516855-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX248913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P095194</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516856-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX233300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLECTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISMANAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSI-ORGANIDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516857-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250683</companynumb>
    <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 MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>5088</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516858-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US250958</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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516859-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-US251923</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>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516860-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-07P-217-0369233-02</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>20030514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516861-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX251133</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>HEPATITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516862-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US251748</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>TABLET; DOSE AND FREQUENCY NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516863-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU244656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P086320</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516864-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-QUU250956</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILK ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516865-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-US251297</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516866-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US248270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516867-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-CAN-05812-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBRAX (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516868-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-GER-05788-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSIDON (OPIPRAMOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516869-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US252184</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>CRYPTOGENIC ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516870-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-US251212</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516871-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US251392</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SAPHO SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SAPHO SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516872-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0680111A</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>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516873-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693090A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516874-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693738A</companynumb>
    <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 FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516875-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694357A</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>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516876-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694387A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>7G26</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516877-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694444A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516878-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694448A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516879-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694452A</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>47.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516880-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494618A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANADOL</medicinalproduct>
        <drugdosagetext>4000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516881-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495158A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYTOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516882-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495249A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>BLOOD ALKALINE PHOSPHATASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANODIL TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITODON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516883-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US251940</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG 2 PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>PREFILLED SYRINGE 50 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG 2 PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516884-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US251942</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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 EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG 2 PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>PREFILLED SYRINGE 50 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG 2 PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516885-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L07-UKI-05273-01</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516886-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-GER-05786-01</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516887-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05785-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516888-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US252294</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516889-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US251480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516890-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05784-01</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516891-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0424175-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516892-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01354</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIFUNGALS</medicinalproduct>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516893-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB01490</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSCAVIR</medicinalproduct>
        <drugauthorizationnumb>020068</drugauthorizationnumb>
        <drugdosagetext>84 MG/KG/DAY GIVEN TWICE DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE, VARIABLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516894-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2006CG02050</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26328</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</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>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516895-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTMIN/CHLORPROMAZINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516896-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2006AP03056</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25673</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051215</drugenddate>
        <drugtreatmentduration>1359</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060624</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516897-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2007SE04991</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15051</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENTELAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAMAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070729</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516898-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06799</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>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE INJECTION</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
        <drugdosagetext>4 ML/H OF THE MIXTURE OF 3 DRUGS</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516899-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01196</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15076</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROPAKINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060723</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060905</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060723</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060723</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060806</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060806</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060806</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060806</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516900-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-FRA-05658-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516901-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005P1000509</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>03330030</drugbatchnumb>
        <drugdosagetext>5 IU; X1; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>03330030</drugbatchnumb>
        <drugdosagetext>5 IU; X1; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>14.4 ML; BID; IV; 4.0 ML; QH; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>14.4 ML; BID; IV; 4.0 ML; QH; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL-  AND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIGLYCERIDE REDUCERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIARRHYTHMICS, CLASS I AND III</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516902-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01091107</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>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL, HYDROGENATED</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516903-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652591A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516904-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652777A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516905-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652797A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516906-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652799A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516907-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652802A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516908-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0652819A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516909-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653271A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516910-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653290A</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516911-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653311A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516912-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653445A</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516913-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653453A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516914-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653455A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516915-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653458A</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>FOREIGN BODY SENSATION IN EYES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516916-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653605A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516917-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653625A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070525</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516918-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653846A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516919-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653847A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516920-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653848A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516921-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653871A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516922-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653873A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070526</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516923-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0653983A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516924-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654002A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070530</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516925-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654010A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516926-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654023A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B229</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516927-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654034A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516928-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654041A</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>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516929-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654053A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516930-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654219A</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516931-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654518A</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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516932-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654519A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516933-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654524A</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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516934-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654539A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516935-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654554A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516936-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654566A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516937-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654774A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516938-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654794A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516939-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654800A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070604</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516940-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654827A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516941-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654948A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516942-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654950A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516943-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654951A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516944-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654970A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516945-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0654973A</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>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516946-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655008A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516947-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655023A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516948-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655178A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516949-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655182A</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>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070607</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516950-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655214A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516951-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655818A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516952-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655821A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516953-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655847A</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>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516954-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655864A</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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516955-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0655870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516956-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656528A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516957-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656534A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516958-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656540A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516959-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656544A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516960-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656565A</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516961-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656579A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516962-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656858A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516963-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656879A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516964-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656883A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516965-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656885A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516966-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0656907A</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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H15</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516967-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657060A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516968-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657074A</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>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516969-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657085A</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>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516970-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657102A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516971-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0657148A</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516972-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658139A</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516973-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658800A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516974-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658835A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516975-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658877A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516976-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658888A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516977-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658898A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070617</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516978-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0658899A</companynumb>
    <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516979-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659081A</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>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516980-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659139A</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>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516981-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005P1000478</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>CT001626</drugbatchnumb>
        <drugdosagetext>5 IU; X2; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>10.6 ML; X1; IV; 4.0 ML; QH; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>CT000800</drugbatchnumb>
        <drugdosagetext>10.6 ML; X1; IV; 4.0 ML; QH; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516982-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659176A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516983-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659576A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516984-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659578A</companynumb>
    <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>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516985-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659583A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516986-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659595A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516987-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659793A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516988-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659797A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516989-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659837A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516990-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0659864A</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516991-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660121A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516992-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660145A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516993-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660146A</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>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516994-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660148A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516995-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660150A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516996-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660151A</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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516997-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660201A</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>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516998-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660359A</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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5516999-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660373A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517000-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660397A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517001-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660856A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517002-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660857A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517003-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660858A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517004-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660860A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517005-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660861A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517006-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660863A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517007-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660884A</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517008-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660888A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517009-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660909A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5J17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517010-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0660941A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517011-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661150A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070605</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517012-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661152A</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517013-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661216A</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>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517014-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661236A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517015-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661570A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517016-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661677A</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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517017-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661686A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517018-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661839A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517019-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0661845A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517020-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662034A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517021-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662053A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517022-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662097A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517023-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662107A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517024-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662114A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517025-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662138A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5A10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517026-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662162A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517027-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662355A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517028-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662417A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517029-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662672A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517030-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662697A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517031-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662701A</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>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517032-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662770A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517033-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0662772A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F12</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517034-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663244A</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>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517035-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663259A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070709</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517036-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663540A</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517037-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663616A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517038-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663647A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517039-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663891A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517040-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663912A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517041-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0663966A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517042-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664210A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070714</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517043-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664242A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517044-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664255A</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>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517045-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664256A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070704</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517046-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664263A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5D25</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>SN9007111</drugbatchnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517047-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664529A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517048-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664545A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6A23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517049-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664719A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517050-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0664734A</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>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517051-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665506A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B08</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517052-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665643A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665731A</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>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517054-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0665746A</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>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517055-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666026A</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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACE CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517056-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666185A</companynumb>
    <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517057-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666274A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666437A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666449A</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>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517060-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666454A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666478A</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>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517062-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666954A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517063-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0666982A</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C07</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517064-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667007A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517065-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667025A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517066-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667200A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667209A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517068-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667210A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517069-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667212A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517070-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667246A</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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517071-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0667255A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668007A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517073-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668033A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517074-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668042A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517075-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668044A</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>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517076-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668064A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517077-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668093A</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517078-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668225A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517079-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668230A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517080-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668263A</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668279A</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517082-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668284A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668523A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517084-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668571A</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>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517085-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668590A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0668909A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5H15</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669083A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517088-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669115A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517089-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669369A</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>COMMIT</medicinalproduct>
        <drugbatchnumb>7B19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517090-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669425A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517091-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669435A</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517092-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669746A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669916A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669917A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517095-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669923A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0669992A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020066</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670057A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670067A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517099-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670069A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517100-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670072A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517101-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670087A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517102-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670293A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517103-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670301A</companynumb>
    <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517104-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-KOR-05265-01</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCTIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517105-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-13974894</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugauthorizationnumb>011283</drugauthorizationnumb>
        <drugindication>EPICONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517106-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0640662A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR SYSTOLIC PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</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>20011019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517107-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0653059A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>F2656A59V</drugbatchnumb>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070502</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517108-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0664046B</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>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYLAK FORTE</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517109-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0667726A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0669242A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0692944A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>4000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517112-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693605A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DANDRUFF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900401</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517113-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693611A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOURETTE'S DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517114-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693624A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugauthorizationnumb>020297</drugauthorizationnumb>
        <drugdosagetext>6.25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugbatchnumb>X6189</drugbatchnumb>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517115-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693741A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694283A</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>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PHOSPHATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694334A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugbatchnumb>R284948,R267064</drugbatchnumb>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517118-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694336A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517119-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694351A</companynumb>
    <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>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517120-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694533A</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517121-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694546A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINNAT</medicinalproduct>
        <drugauthorizationnumb>50672</drugauthorizationnumb>
        <drugdosagetext>5ML TWICE PER DAY</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGINA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE SOLUTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517122-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0435966A</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>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060819</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROGRADUMET</medicinalproduct>
        <drugdosagetext>105MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugdosagetext>2.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517123-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0439519A</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EISENMENGER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051117</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORETEC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCENTRATED RED CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUTHAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517124-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0443070A</companynumb>
    <primarysource>
      <reportercountry>UGANDA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBENDAZOLE</medicinalproduct>
        <drugauthorizationnumb>20666</drugauthorizationnumb>
        <drugdosagetext>400MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELMINTHIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZIQUANTEL</medicinalproduct>
        <drugdosagetext>40MGK SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELMINTHIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517125-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0485056A</companynumb>
    <primarysource>
      <reportercountry>BOTSWANA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIVERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugauthorizationnumb>021205</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517126-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0486672A</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>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517127-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487069A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NAME</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFMETAZON</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517128-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0487650A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</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>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>050754</drugauthorizationnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517129-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0488606A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517130-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0489047A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</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>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517131-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490771A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517132-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490901A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20977</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETENSIEL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SUL INJ</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517133-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491147A</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>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517134-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492054A</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>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17)</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492528A</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZENTEL</medicinalproduct>
        <drugauthorizationnumb>20666</drugauthorizationnumb>
        <drugdosagetext>2TABS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517136-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492743A</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>200MCG AS DIRECTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>200MCG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517137-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492865A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</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>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANKARU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517138-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492872A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCOBAL</medicinalproduct>
        <drugdosagetext>1000MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>958</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELBIN</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517139-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492873A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE</medicinalproduct>
        <drugauthorizationnumb>20549</drugauthorizationnumb>
        <drugdosagetext>100MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COR-TYZINE PEDIATRIC NASAL DROPS</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELTECT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN AIR</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517140-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493268A</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070320</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPUGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517141-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493384A</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>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>72MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>7MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>280MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517142-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493643A</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugauthorizationnumb>21003</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517143-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493731A</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>20487</drugauthorizationnumb>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FACIAL PALSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACIAL PALSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN</medicinalproduct>
        <drugdosagetext>250ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACIAL PALSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517144-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493906A</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>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517145-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494081A</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>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>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE AND METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE SPRAY</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL CFC FREE</medicinalproduct>
        <drugdosagetext>200MCG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517146-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494122A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</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>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugdosagetext>100MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517147-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494292A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>PORIOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KAPOSI'S VARICELLIFORM ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517148-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494437A</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>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
        <drugdosagetext>30TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070207</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517149-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494652A</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>20444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517150-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494695A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDANTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517151-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494707A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIBON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517152-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494751A</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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECOTIDE 250</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>19389</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGODIL</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517153-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495150A</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517154-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495151A</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517155-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495304A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>BRADYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugdosagetext>250MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURESIX</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517156-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495372A</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugauthorizationnumb>020564</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517157-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495373A</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517158-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054517A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugauthorizationnumb>050564</drugauthorizationnumb>
        <drugdosagetext>1000MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INJECTION SITE ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517159-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054840A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517160-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0055100A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517161-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0055103A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>20103</drugauthorizationnumb>
        <drugdosagetext>8MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLO</medicinalproduct>
        <drugdosagetext>4TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>10MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517162-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423803-00</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>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517163-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARTILAGE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517164-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW19764</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>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517165-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-508459</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>CEREBRAL AUTOSOMAL DOMINANT ARTERIOPATHY WITH SUBCORTICAL INFARCTS AND LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUTAMEN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517166-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-530025</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILUTOL</medicinalproduct>
        <drugauthorizationnumb>20136</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517167-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-525634</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>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE INCREASED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOGAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517168-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-529327</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>121.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VX-950</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517169-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200719663GDDC</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>111.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517170-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-514916</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>71.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VX-950</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL + HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSING AMOUNT REPORTED AS 20 / 25 DAILY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DAILY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX CAP</medicinalproduct>
        <drugdosagetext>REPORTED AS ENTEX OLD FORM.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517171-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-530974</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>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517172-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-529086</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517173-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006P1000050</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>76448601</drugbatchnumb>
        <drugdosagetext>5 IU; X1; IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE (RETEPLASE)</medicinalproduct>
        <drugbatchnumb>76448601</drugbatchnumb>
        <drugdosagetext>5 IU; X1; IVB</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>9.5 ML; X1; IVB; 21.6 ML; X1; IV</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABCIXIMAB (ABCIXIMAB)</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>9.5 ML; X1; IVB; 21.6 ML; X1; IV</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517174-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670373A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517175-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670378A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517176-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670428A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517177-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670517A</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>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670548A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517179-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670784A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670825A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517181-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0670847A</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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0671407A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0672448A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0672642A</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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517185-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0672649A</companynumb>
    <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>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0673697A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517187-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674037A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517188-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674093A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517189-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674208A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674256A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0674364A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676240A</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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676244A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676373A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>HL911A</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676563A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676892A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0676926A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517198-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677166A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517199-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677167A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517200-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677225A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517201-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677263A</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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517202-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677275A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677280A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677282A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677651A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677680A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517207-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677687A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677689A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677934A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677944A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677961A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0677983A</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678006A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678009A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678271A</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517216-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678307A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678362A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678644A</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>IMPATIENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678699A</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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517220-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678720A</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>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6G10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678753A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678789A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0678792A</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517224-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679083A</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679097A</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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679150A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679511A</companynumb>
    <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>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679523A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517229-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679543A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679545A</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679553A</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517232-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679920A</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>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679929A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517234-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679933A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679939A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0679977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680001A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>3A20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517238-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680064A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>0621058</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680704A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680736A</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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517241-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680761A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517242-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680800A</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517243-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0680805A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517244-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681366A</companynumb>
    <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517245-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681396A</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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517246-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681413A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517247-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681676A</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517248-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681729A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517249-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681793A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517250-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681962A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517251-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681963A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517252-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0681991A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C07</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517253-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682014A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517254-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682571A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517255-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682573A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517256-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682581A</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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>2K18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517257-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682613A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517258-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682636A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517259-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682642A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517260-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682921A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517261-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682926A</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>BUCCAL MUCOSAL ROUGHENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517262-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682970A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517263-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0682982A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7H11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517264-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683226A</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517265-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683256A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517266-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683278A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517267-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683439A</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C260</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517268-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683508A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517269-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683667A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517270-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0683704A</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517271-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684043A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DEPRESSIVE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517272-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684237A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6J02</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517273-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684238A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A17</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517274-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684264A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684272A</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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E31</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517276-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684565A</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>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517277-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684583A</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>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517278-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684622A</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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>CD10</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517279-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684897A</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517280-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684906A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517281-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684945A</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684951A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517283-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0684977A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517284-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685211A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517285-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685230A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B22</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517286-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685232A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517287-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685246A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I14</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517288-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685482A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517289-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0685491A</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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517290-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686029A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517291-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686068A</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>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517292-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686076A</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7O16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517293-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686098A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517294-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686228A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517295-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP019109</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>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517296-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686231A</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6C06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517297-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686272A</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5105</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517298-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686317A</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>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>5LOZ PER DAY</drugdosagetext>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517299-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686516A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517300-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686521A</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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517301-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686614A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517302-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686815A</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686817A</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686866A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517305-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0686870A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687061A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517307-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687088A</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>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517308-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687100A</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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K28</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517309-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687429A</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>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517310-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687440A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6L04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517311-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687816A</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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517312-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687819A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517313-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687829A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D18</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517314-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687866A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517315-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687939A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517316-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0687949A</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>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7C05</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517317-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688117A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6F19</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517318-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688131A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517319-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688153A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D16</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517320-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688178A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517321-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688184A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E07</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517322-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688206A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517323-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688222A</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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517324-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688401A</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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517325-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688666A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517326-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688827A</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6D24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517327-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688843A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517328-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0688849A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517329-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689093A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517330-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689428A</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517331-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689429A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517332-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689448A</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>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7B06</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517333-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689484A</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>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517334-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689503A</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>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517335-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689518A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517336-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689523A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517337-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689689A</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7I04</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517338-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689700A</companynumb>
    <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>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517339-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689753A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6K01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517340-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689943A</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>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7A30</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517341-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689984A</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>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>5I26</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517342-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689985A</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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E23</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517343-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0689989A</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>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H09</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517344-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690000A</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>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517345-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690191A</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6H24</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517346-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690244A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7D11</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517347-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690281A</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6E01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517348-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690421A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517349-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690468A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>6I20</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517350-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690731A</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>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7E21</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517351-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A0690747A</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 PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMMIT</medicinalproduct>
        <drugbatchnumb>7F01</drugbatchnumb>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517352-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-US241655</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMADORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>1 DOSE EVERY 1 PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517353-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011116</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>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>75831</drugauthorizationnumb>
        <drugdosagetext>2.5 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517354-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US011693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSFUNCTIONAL UTERINE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>P039083,P007977</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US250639</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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>3 MG; UNSPECIFIED FREQUENCY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>2 TABLETS; UNSPECIFIED FREQUENCY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG X 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2 MG X 4 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517356-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US223560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS GRAFT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARNITINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517357-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423493-00</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517358-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US187725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P057906</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517359-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011119</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>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>76671</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517360-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PURDUE-GBR_2007_0003392</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL REFLEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>10 MG, AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>20 MG, PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517361-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW18615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW12212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>588</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG INEFFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517363-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW05498</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>
      <patientweight>70.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>121</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>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070208</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 UG TWO INHALATIONS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517365-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>159.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25MG-150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>25MG-150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5MG-5MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5MG-5MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517366-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GENENTECH-250989</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>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517367-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-UK251284</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517368-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE608410APR03</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517369-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-UK251282</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL BLOOD STEM CELL APHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-UK251283</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGLOTTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517371-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-UK251279</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL BLOOD STEM CELL APHERESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517372-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-251133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517373-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US245155</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517374-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA03799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASTIC NAEVUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517375-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-0711NLD00014</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>020408</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517376-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0711BRA00018</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01722</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517378-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05066</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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAILURE OF IMPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0709GBR00062</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517380-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-AMGEN-US251308</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHYLOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENENTECH-251223</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>GINGIVITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517382-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-UK251278</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPIVANCE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517383-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1011120</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>77195</drugauthorizationnumb>
        <drugdosagetext>250 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517384-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200720273GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517385-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200720310GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGAFOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX                           /00340101/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517386-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200715237EU</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDEX                             /00340101/</medicinalproduct>
        <drugauthorizationnumb>18538</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUITEL                            /00810601/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOLASTAN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPECYCLAL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517387-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200720297GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PHARYNGOTONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PHARYNGOTONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugbatchnumb>ANL7AG</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugbatchnumb>ANL7AG</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILLEN CAP</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILLEN CAP</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMAGEL                            /00909601/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMAGEL                            /00909601/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIFED                            /00005601/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTUSS                           /00884201/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA                             /00024201/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA                             /00024201/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517388-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200719201GDDC</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517389-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-AMGEN-US241193</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517390-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-AMGEN-US233276</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517391-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334333</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE (DIPHENHYDRAMINE)</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517392-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0348809A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL (FORMULATION UNKNOWN) (ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517393-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074216</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>879.3 - 999 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517394-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>118-C5013-07060150</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CC-5013 (LENALIDOMIDE) (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40 MG, DAILY ON DAYS 1-4,9-12,17-20 OF 28D CYCL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517395-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007CH003889</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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>180 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>525 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00596407</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007CH003888</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGYL /00137201/ (CLEMASTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517398-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>022-20785-07100263</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, 8 IN 1 D, ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, 8 IN 1 D, ORAL ; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517399-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071109</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_00647_2007</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APO-GO (APO-GO - APOMORPHINE HYDROCHLORIDE) (NOT SPECIFIED)</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>(5.5 MG PER HOUR FOR 12 HOURS/DAY SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR 125 (CO-BENELDOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR 62.5</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR 125SR (CO-BENELDOPA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517400-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976865</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>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517401-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13624416</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517402-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CY-BRISTOL-MYERS SQUIBB COMPANY-13980537</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECEIVED ON 06FEB06.CETUXIMAB-2 MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517403-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11202</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 10MG TABLETS</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517404-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD ALTERNATING BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMNESTEEM (MYLAN)</medicinalproduct>
        <drugdosagetext>40 MG,QD ALTERNATING BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517405-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517406-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11187</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 20MG TABLETS</medicinalproduct>
        <drugbatchnumb>10705 DEXCEL PHARMA</drugbatchnumb>
        <drugauthorizationnumb>76285</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 50MG</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517407-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11199</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISPERSIBLE ASPIRIN 75MG TABLETS BP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL TABLETS BP 500MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11188</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN BASICS B 600MG FILMTABLETTEN</medicinalproduct>
        <drugauthorizationnumb>76605</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 50MG</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM TABLETS BP 10MG</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXERUTINS</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOSEDYL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4.5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-11197</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE FILM COATED TABLET 750MG</medicinalproduct>
        <drugauthorizationnumb>65102</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE TABLETS 400MG</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN XL</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>250 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>10 ML, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL CAPSULES 500MG</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 10MG TABLETS</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517410-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-247249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.247</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>15 MG/KG, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>98.4 MG/M2, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>3.4 AUC, UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517411-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0419610-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugdosagetext>TWO DOSES TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC125</medicinalproduct>
        <drugdosagetext>TWO DOSES TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTOPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPOGONADISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPOGONADISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON/PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAPILLOMA VIRAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517412-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2007RR-09859</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LICHENOID KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL TABLETS BP 100MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN TABLETS BP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517413-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-249885</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>8 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517414-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-250595</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.3 ML, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517415-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N76770</drugbatchnumb>
        <drugdosagetext>15 MG/KG, WKS 1 + 4</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071011</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>50 MG/M2, WK 1-6</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, Q6H</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>2 TSP, QAM</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, QHS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517416-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423558-00</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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID FILMTABS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT TURBOHALER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517417-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H01052807</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>
      <patientweight>96.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFABULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>20 MG, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>48 MG, FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517418-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>5.8 MG/KG;</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517419-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>4 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517420-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517421-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000293</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>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>3.5MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>3.5MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE /00252502/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET /00758701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517422-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517423-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071004712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>Q1D</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517424-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-JNJFOC-20071102396</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>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDUM FOLICUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517425-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20070502370</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTARIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>LYMPHADENITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFREE S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517426-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CATHETER SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517427-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000291</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517429-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000244</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>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517430-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000217</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>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG;Q48H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517431-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2007S1000194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>4.5 MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCOSATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517432-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2004GB02339</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>605</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERIVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010828</drugenddate>
        <drugtreatmentduration>483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIENE</medicinalproduct>
        <drugdosagetext>50 MICROGRAMS PER GRAM</drugdosagetext>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517433-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01555</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17370</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517434-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2007GB02244</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517435-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01548</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29257</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517436-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423495-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517437-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-07P-028-0423686-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517438-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26047</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>D.O.R.C. VISION BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517439-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26035</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517440-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IS-ASTRAZENECA-2007SE05970</companynumb>
    <primarysource>
      <reportercountry>ICELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>100 MG+200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517441-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517442-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26060</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAN-DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RATIO-METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517443-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26034</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>D.O.R.C. VISION BLUE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517444-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517445-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26046</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-HYDRAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RATIO-METFORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517446-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N38279</drugbatchnumb>
        <drugdosagetext>745 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>JOINT STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517447-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARALAST</medicinalproduct>
        <drugbatchnumb>VNB5F024</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALPHA-1 ANTI-TRYPSIN DEFICIENCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT                               /GFR/</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517448-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423490-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE MONOSODC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517449-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14370</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>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517450-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE02869</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>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517451-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-07P-013-0423691-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051212</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517452-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-07P-007-0423692-00</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</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>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS SKIN TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517453-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0420974-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTIRGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517454-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES10329</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517455-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE15513</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA EVACUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD001</medicinalproduct>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>225 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517456-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03588</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</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>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517457-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP14692</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</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>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070510</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYSRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061130</drugenddate>
        <drugtreatmentduration>192</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517458-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007094103</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>STENT RELATED INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517459-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007093002</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517460-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30.454</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007027264</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517462-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006153158</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517463-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007072968</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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517464-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007018566</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBUCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517465-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07092</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>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01599</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27268</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517467-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007SE06032</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>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517468-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2004082357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517469-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007074081</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>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517470-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-WYE-G00558907</companynumb>
    <primarysource>
      <reportercountry>FINLAND</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugdosagetext>1000 IU EVERY 1 TOT</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517471-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-WYE-G00488607</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>225 MG AND TAPERING OFF</drugdosagetext>
        <drugindication>PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517472-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE396422JUL05</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020527</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517473-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007082439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>102899</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517474-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007080075</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>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABASERIL</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TALVOSILEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRONAJOD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517475-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-530509</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517476-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-529971</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517477-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517478-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-530725</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>DOSAGE/REGIMEN REPORTED AS ^DAY^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>DOSAGE/REGIMEN REPORTED AS ^DAY^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DOSAGE/REGIMEN REPORTED AS ^DAY^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DOSAGE/REGIMEN REPORTED AS ^DAY^.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ^TRITICO^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517479-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007074771</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUMESTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517480-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517481-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2007013604</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517482-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2007033605</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRONTAL</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLIVITAMINICO</medicinalproduct>
        <drugdosagetext>TEXT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517483-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006133682</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517484-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2006137623</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SU-011,248</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517485-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006147340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517486-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2005047340</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DECALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXAMED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517487-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>TRAUMATIC BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugbatchnumb>00096FA</drugbatchnumb>
        <drugauthorizationnumb>084349</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517488-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007073685</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 500-D</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517489-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071103454</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>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517490-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071002152</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517491-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071002155</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517492-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071002156</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517493-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103342</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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517494-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071103421</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALINOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517495-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20070902903</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>HOMICIDE</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517496-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDRENS TYLENOL PLUS COUGH + SORE THROAT CHERRY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517497-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071104387</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>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>7841550</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>7841550</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS AND MINERALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517498-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071104847</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>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517499-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20071102552</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>15923</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERALITHE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517500-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071102906</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL DECANOAT</medicinalproduct>
        <drugauthorizationnumb>18701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517501-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071103437</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOMINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGIMERCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517502-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007072182</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:3GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517503-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007071431</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>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517504-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0420268-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTID GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517505-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007076866</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>TEXT:2 PUFFS EVERY 4 TO 6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517506-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0423967-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517507-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0421970-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITIGLINIDE CALCIUM HYDRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517508-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007068630</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517509-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-001112</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517510-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2007US-11367</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>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>076041</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID (PREDNISONE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517511-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007065265</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517512-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-SHR-IE-2007-042529</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>UNK, 1 DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517513-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-012270</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5395A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>1000 MG, EVERY 2D</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, EVERY 2D</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517514-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-015920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5395A</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5395A</drugbatchnumb>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517515-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-022853</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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA7328A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517516-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-023505</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-000256</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517518-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20060702878</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>CONGENITAL GENITAL MALFORMATION</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>STRATTERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517519-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20071102416</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517520-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070901595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517521-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070904507</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>92.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROBIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-026729</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>106.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA7307A</drugbatchnumb>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070628</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-013051</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5393A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D AT BEDTIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517524-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2007BH007303</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-1</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIONEAL</medicinalproduct>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517525-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007068582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517526-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BAXTER-2007BH008720</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>0708009</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>507H05447</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUCINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLVITE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANPRODACT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517527-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-034741</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>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517528-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-012768</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THYROID DRUG</medicinalproduct>
        <drugindication>THYROID FUNCTION TEST ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517529-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES200711001112</companynumb>
    <primarysource>
      <reportercountry>SPAIN</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>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517530-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007066051</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517531-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-027316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>6 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070721</drugenddate>
        <drugtreatmentduration>64800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>4 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517532-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-016109</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>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3530A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517533-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-006728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4111A</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517534-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-025386</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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5734A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517535-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-037193</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>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DEPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>VB3338A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517536-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2006-035469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA3095A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517537-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-012130</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517538-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007041484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517539-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-017307</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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070426</drugenddate>
        <drugtreatmentduration>652</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517540-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-018962</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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA5737A</drugbatchnumb>
        <drugdosagetext>16 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
        <drugtreatmentduration>285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517541-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-009440</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA4599A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREFOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA (SITAGLIPTIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517542-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-010530</companynumb>
    <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>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517543-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-011523</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>INTRAOCULAR MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517544-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-PFIZER INC-2007063889</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISIDON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517545-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007058789</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517546-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007036240</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>TEXT:25 AND 50MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517547-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007093727</companynumb>
    <primarysource>
      <reportercountry>GERMANY</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517548-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2007BH008437</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>07H17G37</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>07H31G38</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PD4</medicinalproduct>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517549-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP05538</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517550-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2006GB00815</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>021109</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517551-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP05545</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517552-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007089664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517553-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007084173</companynumb>
    <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517554-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517555-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080101</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>CARPAL TUNNEL DECOMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517556-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WYE-G00554007</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517557-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007081457</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517558-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007080053</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517559-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041568</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>69.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517560-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-036098</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>129.25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANT DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517561-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-027477</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>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>WA6951B</drugbatchnumb>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.25 MG, 1X/DAY</drugdosagetext>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517562-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
        <drugindication>CRYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO/OVRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517563-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-038820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 A?G/DAY, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517564-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-041884</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517565-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-039787</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>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, 1X/MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517566-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-028156</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517567-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-033047</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517568-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007078828</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>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517569-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-US-2007-034084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517570-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007077336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>TEXT:2 PILLS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517571-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007092074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517572-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007075740</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>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOTRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEETH BRITTLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERYDAY</drugdosagetext>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>TEXT:EVERYDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517573-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007069363</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>ARTHROSCOPIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517574-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007094004</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517575-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200711475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517576-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2007088074</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugindication>ADRENAL GLAND CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:170MG</drugdosagetext>
        <drugindication>ADRENAL GLAND CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugdosagetext>TEXT:2-9 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL GLAND CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTONIN-H</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REXER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517577-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-A01200712707</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>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517578-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A01200712498</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>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>TOTAL OF 160 MG OVER 5 MIN (BOLUS OF 20 MG, 20 MG, 40 MG, 40 MG AND 40 MG)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PETHIDINE</medicinalproduct>
        <drugauthorizationnumb>005010</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>A COUPLE OF BEERS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517579-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092548</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517580-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200703279</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugauthorizationnumb>011287</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517581-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-SYNTHELABO-A02200703287</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517582-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200705398</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517583-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007089766</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>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABASERIL</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACOM ^MSD^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517584-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706287</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517585-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517586-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007086775</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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOID PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESSURE OF SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUSPICIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517587-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0421740-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-LYSINE ACETYLSALICYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSTERENE SODIUM SULFONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517588-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007087639</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPRODONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVINE ADENINE DINUCLEOTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517589-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-07P-020-0423718-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517590-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423551-00</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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</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>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517591-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007087372</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517592-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085523</companynumb>
    <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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517593-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007083826</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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517594-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROVESICAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATES ENEMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>TEXT:5/325</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517595-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007085497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517596-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093051</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517597-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093004</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>020287</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517598-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-SYNTHELABO-F01200701448</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517599-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093031</companynumb>
    <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLESTID TABLET</medicinalproduct>
        <drugauthorizationnumb>20222</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517600-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENENTECH-246664</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070621</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGIMERCK</medicinalproduct>
        <drugdosagetext>0.07 UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517601-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2007092654</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>FREQ:DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517602-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-SYNTHELABO-F01200701469</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517603-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092579</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517604-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007092554</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517605-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517606-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0366200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>393439A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517607-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0424455-00</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>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NRTIS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517608-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0423713-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIOGEST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517609-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-07P-056-0423494-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROPAKINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROPAKINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROPAKINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROPAKINE GRANULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STIRIPENTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517610-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL LAMINECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517611-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007093277</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </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>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517612-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517613-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <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>AVANDIA</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517614-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.454</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517615-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517616-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2007093505</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEX</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERONEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517617-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN/GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517618-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007093358</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEVELOPMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517619-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093762</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517620-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007093835</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>020287</drugauthorizationnumb>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOC ^BYK MADAUS^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517621-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2007093745</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHANTOM PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517622-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517623-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2007094356</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMESSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517624-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517625-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517626-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2007094010</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>1</drugcharacterization>
        <medicinalproduct>CHAMPIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517627-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007088015</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 DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>20682</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:150MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLITOL TABLET</medicinalproduct>
        <drugauthorizationnumb>020682</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSENNID</medicinalproduct>
        <drugdosagetext>DAILY DOSE:24MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIKENTYUTO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517628-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094945</companynumb>
    <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 DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517629-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2007094640</companynumb>
    <primarysource>
      <reportercountry>CHILE</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>020664</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517630-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007094566</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517631-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24222RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGONADISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>075997</drugauthorizationnumb>
        <drugindication>CACHEXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>040054</drugauthorizationnumb>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076246</drugauthorizationnumb>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROAD-SPECTRUM ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517632-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24223RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGONADISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>075997</drugauthorizationnumb>
        <drugindication>DECREASED APPETITE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMEXON</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517633-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24224RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGONADISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugauthorizationnumb>075997</drugauthorizationnumb>
        <drugindication>CACHEXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517634-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24227RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION INHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugauthorizationnumb>040528</drugauthorizationnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>076213</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517635-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROXANE LABORATORIES, INC-2007-BP-24375RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>88803</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517636-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROXANE LABORATORIES, INC-2007-BP-24228RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EVIDENCE BASED TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517637-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROXANE LABORATORIES, INC-2007-BP-24216RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>040032</drugauthorizationnumb>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>040054</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>ACUTE GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517638-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24217RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugauthorizationnumb>073079</drugauthorizationnumb>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>BACTERIA STOOL IDENTIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517639-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROXANE LABORATORIES, INC-2007-BP-24236RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>074190</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517640-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC-2007-BP-24215RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>074069</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugauthorizationnumb>080352</drugauthorizationnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROAD SPECTRUM ANTIBIOTICS</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517641-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007094487</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>TAHOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517642-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2007095055</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAZOCHROME SODIUM SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517643-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22352BP</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>APPLICATION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-1</medicinalproduct>
        <drugbatchnumb>0541843</drugbatchnumb>
        <drugauthorizationnumb>018891</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517644-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23208BP</companynumb>
    <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 OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517645-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06678DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-BLOCKER</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517646-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24270BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705391A,7C2222</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517647-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22125BP</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>HYPERSEXUALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517648-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23185BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517649-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-07479BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20070427</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517650-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24348BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517651-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23133BP</companynumb>
    <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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517652-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24346BP</companynumb>
    <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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX NEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517653-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23150BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>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>20070714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517654-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24330BR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR / RITONAVIR CAPSULES</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517655-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23145BP</companynumb>
    <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 BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517656-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24447PB</companynumb>
    <primarysource>
      <reportercountry>PERU</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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517657-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24445BR</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>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>608356</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIGENIO</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-SPECIFIED SUBSTANCE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517658-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23134BP</companynumb>
    <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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517659-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24321BP</companynumb>
    <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517660-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-DE-06020DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517661-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24257BP</companynumb>
    <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A28317</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517662-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24412BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517663-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24395YA</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517664-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-24347BP</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517665-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23108BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517666-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23141BP</companynumb>
    <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>SPIRIVA</medicinalproduct>
        <drugbatchnumb>705255B,7C2222</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517667-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23211BP</companynumb>
    <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>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY VITAMIN</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517668-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23034BP</companynumb>
    <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 PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOOST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AND OTHER MEDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517669-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21257BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609029,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>609029,NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517670-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-20611BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703786A,7C3200</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517671-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-18407BP</companynumb>
    <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>703585A,7C2217</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517672-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23113BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517673-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-21988BP</companynumb>
    <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>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517674-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23182BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517675-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23168BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23106BP</companynumb>
    <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>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517677-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23247BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517678-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23096BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517679-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071016</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-22928BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517680-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23135BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517681-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23136BP</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>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</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>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517682-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23137BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517683-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23140BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517684-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2007-BP-23151BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517685-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250870</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>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>70 MG, 1/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517686-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GENENTECH-246477</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517687-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00748207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugbatchnumb>2005P1411; 2005P0561</drugbatchnumb>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070903</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugbatchnumb>2005P1411; 2005P0561</drugbatchnumb>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>400 - 80 MG TWICE A DAY ON MONDAY-TUESDAY - WEDNESDAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517688-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GENENTECH-250968</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTERIOR CHAMBER FLARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN OPHTHALMIC SOLUTION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517689-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX200710003748</companynumb>
    <primarysource>
      <reportercountry>MEXICO</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>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517690-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A307405</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </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>90 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517691-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517692-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000995</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2/D</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517693-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710006397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517694-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 D/F, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517695-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001852</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A388336</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPSOM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517696-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001741</companynumb>
    <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 BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>1 D/F, EACH MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>4.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517697-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001716</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711001849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICYCLIC ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517699-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711000484</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>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUASYM</medicinalproduct>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUASYM</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-GENENTECH-249908</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CAVITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070822</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GENENTECH-250846</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>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517702-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250973</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>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>5 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>100 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517703-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250757</companynumb>
    <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCUFLOX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517704-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250827</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METALYSE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517705-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREVIBLOC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND EPINEPHRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517706-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250917</companynumb>
    <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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517707-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007000931</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150  MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517708-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005002275</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>
      <patientweight>53.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB HCI) (TABLET) (ERLOTINIB HCI)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>125 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517709-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML; BID; INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517710-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET)</medicinalproduct>
        <drugbatchnumb>P426101</drugbatchnumb>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugbatchnumb>N23519</drugbatchnumb>
        <drugdosagetext>10 MG/KG, Q2W, INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517711-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (ERLOTINIB HCI) (TABLET) (ERLOTINIB HCI)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>1149 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517712-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007002094</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB (TABLET)</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (INJECTION FOR INFUSION)</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-MAG (MAGNESIUM CHLORIDE ANHYDROUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VER_00077_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugauthorizationnumb>20800</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DAV-AE-CLO-07-008</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCI</medicinalproduct>
        <drugbatchnumb>63426A</drugbatchnumb>
        <drugauthorizationnumb>71783</drugauthorizationnumb>
        <drugdosagetext>0.1 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE HCI</medicinalproduct>
        <drugbatchnumb>63426A</drugbatchnumb>
        <drugauthorizationnumb>71783</drugauthorizationnumb>
        <drugdosagetext>0.1 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>200 MD BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021601</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>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugdosagetext>400 MG QAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG QAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517717-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2007A02165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517718-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-11972</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>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517719-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-1164343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugauthorizationnumb>21598</drugauthorizationnumb>
        <drugdosagetext>(2 GTT Q1H OPHTHALMIC)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ULCERATIVE KERATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517720-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREVIBLOC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND EPINEPHRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0418453-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517722-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-07P-062-0423560-00</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugdosagetext>15 TABLETS IN ONE DOSE</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517723-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430036M07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238974K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517725-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239443K07USA</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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517726-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334412</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19.0511</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL PUSTULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE BUBBLE BLAST (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>41266L</drugbatchnumb>
        <drugdosagetext>CAPFUL, ONCE A DAY (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517727-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREVIBLOC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOTRACHEAL INTUBATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND EPINEPHRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517728-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>A PINT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517729-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0706USA04847</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>104.7809</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT 100 MG</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 300 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT 100 MG</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 300 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.9 MG/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>0.7 MG/M(2)/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517730-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0711USA00219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.2449</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT UNK</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>50 MG/M[2]/1X/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517731-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0710USA02946</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>63.9572</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT UNK</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENOXYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517732-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0708USA04134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT UNK</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 400 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP VORINOSTAT UNK</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG/DAILY/PO; 400 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ DECITABINE UNK</medicinalproduct>
        <drugdosagetext>20 MG/M[2]/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ DECITABINE UNK</medicinalproduct>
        <drugdosagetext>20 MG/M[2]/DAILY/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517733-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12230</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517734-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12124</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>1 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>1 MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>POLYURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517735-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517736-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517737-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ABBOTT-07P-118-0424409-00</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517738-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-07P-163-0424517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APTIVUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517739-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-06P-127-0326353-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYPTOSPORIDIOSIS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</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>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517740-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED), INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED), INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517741-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517742-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517743-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007110698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugauthorizationnumb>18449</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517744-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPI-P-002343</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>9 GM (4.5 GM, 2 IN 1 D); ORAL, 12 GM (6 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>9 GM (4.5 GM, 2 IN 1 D); ORAL, 12 GM (6 GM, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE(FLUTICASONE PROPIONATE) (INHALANT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE(METFORMIN W/ROSIGLIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON(RAMELTEON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517745-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11528</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILK-ALKALI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (NCH)(CALCIUM CARBONATE) UNKNOWN</medicinalproduct>
        <drugdosagetext>500 MG,TID;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE,CHOLECALCIFEROL (NCH)(CHOLECALCIFEROL, CALCIUM CARBO</medicinalproduct>
        <drugdosagetext>500 MG/200 IU, TID,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugdosagetext>60 MG, QD;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517746-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GENENTECH-250333</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 G, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2/WEEK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, 1/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>25 MG, 2/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugdosagetext>40 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1/WEEK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517747-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2007US11718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX REG STR CHOCOLATED LAX PCS SEN (NCH)(SENNA GLYCOSIDES (CA SALTS</medicinalproduct>
        <drugdosagetext>90 MG, PER DAY, SINCE SHE WAS AN INFANT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517748-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE BUBBLE BLAST (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>40206L</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYRTEC (CETIRIZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517749-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007332591</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>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE AGENT COOL BLUE BUBBLE BLAST (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugbatchnumb>00566L</drugbatchnumb>
        <drugdosagetext>10 ML 1 TIME PER DAY (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517750-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334702</companynumb>
    <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>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENGAY PAIN RELIEVING PATCH (MENTHOL)</medicinalproduct>
        <drugbatchnumb>M1375C1</drugbatchnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517751-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEDIACARE GENTLE VAPORS (NO ACTIVE INGREDIENT)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517752-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYES SUNKEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>3/4 TEASPOON EVERY 4 - 6 HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517753-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007332619</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</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>ROGAINE 5</medicinalproduct>
        <drugauthorizationnumb>21812</drugauthorizationnumb>
        <drugdosagetext>ONE TIME, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517754-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>N38279</drugbatchnumb>
        <drugdosagetext>745 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SUL TAB</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>JOINT STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517755-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007334401</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURELL UNSPECIFIED (ETHYL ALCOHOL)</medicinalproduct>
        <drugdosagetext>THE WHOLE BOTTLE, 2 TIMES IN 10 MINUTES, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517756-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1002202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40298</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517757-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG;DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>500 MG;DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10 MG;DAILY;ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPENIDYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517758-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US09411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY SPHINCTEROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>64150</drugauthorizationnumb>
        <drugdosagetext>600 MG/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE (PYRIDOXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517759-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2007Q01425</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>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugauthorizationnumb>19010</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1 IN 1 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXCESSIVE SEXUAL FANTASIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEETS ENEMA (PARAFFIN, LIQUID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517760-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>120.13 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517761-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074204</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>360.47 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517762-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517763-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074101</companynumb>
    <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>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517764-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-247855</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>98</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517765-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-249780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517766-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA01909</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517767-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA04747</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>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESORPTION BONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517768-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00333</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517769-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA04807</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517770-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA05883</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>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051011</drugenddate>
        <drugtreatmentduration>1972</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517771-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0705USA00760</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORTON'S NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061012</drugenddate>
        <drugtreatmentduration>310</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517772-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0708USA05124</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517773-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0711AUS00076</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517774-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA02015</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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517775-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA02361</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>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA PAROXYSMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517776-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0704USA04779</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>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</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>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517777-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZW-GILEAD-2007-0014228</companynumb>
    <primarysource>
      <reportercountry>ZIMBABWE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517778-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0505USA01427</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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX (MORNIFLUMATE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517779-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA02024</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>GLOBAL AMNESIA</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>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517780-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0702NOR00010</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517781-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0710NOR00005</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517782-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01927</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517783-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0510USA07346</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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517784-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0711GBR00031</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517785-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA05062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</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>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517786-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA02980</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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESORPTION BONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCIATIC NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517787-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517788-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20074229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>1497 MCG, DAILY, INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517789-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugindication>FABRY'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517790-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2007-0013515</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFINAH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517791-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US000991</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>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517792-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002750</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>PERINEPHRIC COLLECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>9 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS (FOLIC ACID, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM (DIPHENHYDRAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517793-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2005US001772</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>CEREBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517794-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002755</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517795-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US001986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAPRISOL</medicinalproduct>
        <drugauthorizationnumb>21697</drugauthorizationnumb>
        <drugdosagetext>20 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>HYPONATRAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517796-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PULMONARY FIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517797-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2007-18341</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 CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517798-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022362</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517799-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022385</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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517800-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HP200700096</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>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANAFIL (PAPAIN, UREA, CHLOROPHYLLIN SODIUM COPPER COMPLEX) SPRAY</medicinalproduct>
        <drugdosagetext>QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DIABETIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX (MORNIFLUMATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517801-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.382</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517802-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>071004566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.0709</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUATE SINUS CONGESTION AND PAIN (GUAIFENESIN, ACETAMINOPHEN,PHENYLEPH</medicinalproduct>
        <drugbatchnumb>P43343</drugbatchnumb>
        <drugdosagetext>2TAB, B.I.D., ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
        <drugbatchnumb>38057</drugbatchnumb>
        <drugdosagetext>2TSP, B.I.D., ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517803-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517804-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009578</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>90.7194</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL TRANSDERMAL SYSTEM</medicinalproduct>
        <drugbatchnumb>6S0003</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>12 UG/HR; EVERY 3 DAYS; TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM INTENSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517805-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1009361</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>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40298</drugauthorizationnumb>
        <drugdosagetext>300 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517806-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-07P-144-0423521-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517807-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0013803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517808-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG/3ML;BID;INHALATION , 0.63 MG/3ML;TID;INHALATION , 0.63 MG/3ML;QD;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG/3ML;BID;INHALATION , 0.63 MG/3ML;TID;INHALATION , 0.63 MG/3ML;QD;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG/3ML;BID;INHALATION , 0.63 MG/3ML;TID;INHALATION , 0.63 MG/3ML;QD;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517810-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0711S-0442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GADOVERSETAMIDE(OPTIMARK)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517811-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01332</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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSMOPREP</medicinalproduct>
        <drugauthorizationnumb>21892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517812-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP01240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSMOPREP</medicinalproduct>
        <drugauthorizationnumb>21892</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517813-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003723</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML;BID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML;BID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517814-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP003705</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>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML;BID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROVANA</medicinalproduct>
        <drugauthorizationnumb>21912</drugauthorizationnumb>
        <drugdosagetext>15 UG/2ML;BID;INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517815-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021047</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>6-CO-4003</drugbatchnumb>
        <drugdosagetext>30 MCG;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugbatchnumb>6RCJ037</drugbatchnumb>
        <drugdosagetext>600 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P092190</drugbatchnumb>
        <drugdosagetext>40000 IU;QW;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUALAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517816-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP014995</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>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>7A09BH</drugbatchnumb>
        <drugauthorizationnumb>22015</drugauthorizationnumb>
        <drugdosagetext>2 DF; QD; PO, 18 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>7A09BH</drugbatchnumb>
        <drugauthorizationnumb>22015</drugauthorizationnumb>
        <drugdosagetext>2 DF; QD; PO, 18 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517817-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022341</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>7RXF21</drugbatchnumb>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>1 DF; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>7RXF21</drugbatchnumb>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>1 DF; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SNEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517818-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517819-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022110</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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>7B01BH</drugbatchnumb>
        <drugauthorizationnumb>22015</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517820-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014347</companynumb>
    <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>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517821-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>22015</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517822-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022001</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>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517823-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX001491</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>84.8226</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN PLATELET VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>9 UG;QD; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517824-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEP_00052_2007</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>111.1313</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>06T13621A</drugbatchnumb>
        <drugauthorizationnumb>21748</drugauthorizationnumb>
        <drugdosagetext>2000MG, ORAL, 500 MG, ORAL, 1000 MG, ORAL, 1500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>06T13621A</drugbatchnumb>
        <drugauthorizationnumb>21748</drugauthorizationnumb>
        <drugdosagetext>2000MG, ORAL, 500 MG, ORAL, 1000 MG, ORAL, 1500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>06T13621A</drugbatchnumb>
        <drugauthorizationnumb>21748</drugauthorizationnumb>
        <drugdosagetext>2000MG, ORAL, 500 MG, ORAL, 1000 MG, ORAL, 1500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>06T13621A</drugbatchnumb>
        <drugauthorizationnumb>21748</drugauthorizationnumb>
        <drugdosagetext>2000MG, ORAL, 500 MG, ORAL, 1000 MG, ORAL, 1500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517825-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTINUOUS HAEMODIAFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORYNEBACTERIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>63 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>155 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>685 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517826-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CLOF-10700</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>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE. MFR: GENZYME</medicinalproduct>
        <drugbatchnumb>89781051</drugbatchnumb>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>40 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 QD X 5 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVERSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISRADIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517827-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517828-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-02861</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>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2 ; 1.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517829-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517830-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517831-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-00462</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>102.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>66.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT HFA (IPRATROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517832-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2007-0013760</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM LOW</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDIFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517833-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03315</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>60.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2 ; 1.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2 ; 1.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2 ; 1.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2 ; 1.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG ; 40.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG ; 40.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG ; 40.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugdosagetext>40.00 MG ; 40.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200.00 MG ; 200.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200.00 MG ; 200.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200.00 MG ; 200.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200.00 MG ; 200.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN RDF</medicinalproduct>
        <drugdosagetext>10.00 MG/M2 ; 7.50 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400.00 MG/M2 ; 300.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400.00 MG/M2 ; 300.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400.00 MG/M2 ; 300.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>400.00 MG/M2 ; 300.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40.00 MG/M2 ; 30.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40.00 MG/M2 ; 30.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40.00 MG/M2 ; 30.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>40.00 MG/M2 ; 30.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN(MELPHALAN) VIAL</medicinalproduct>
        <drugdosagetext>140.00 MG/M2 ; 140.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN(MELPHALAN) VIAL</medicinalproduct>
        <drugdosagetext>140.00 MG/M2 ; 140.00 MG/M2</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517834-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05816-01</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>CHORIORETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL #3                    (ACETAMINOPHEN AND CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA            (ABATACEPT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517835-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42333</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>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>2074-42-958651</drugbatchnumb>
        <drugauthorizationnumb>76018</drugauthorizationnumb>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517836-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ELI_LILLY_AND_COMPANY-PT200709006695</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A341129</drugbatchnumb>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517837-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>42326</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>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>2074-42-958651</drugbatchnumb>
        <drugauthorizationnumb>76018</drugauthorizationnumb>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517838-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1000273</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>67.1324</patientweight>
      <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>OLUX</medicinalproduct>
        <drugauthorizationnumb>21142</drugauthorizationnumb>
        <drugdosagetext>0.05 PCT;PRN;TOP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517839-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VNL_00699_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40.3701</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APOKYN</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>DF, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517840-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CVT-070177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA                    (RANOLAZINE)             FILM-COATED TABLET</medicinalproduct>
        <drugauthorizationnumb>21526</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE               (ISOSORBIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517841-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07-443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>244297C</drugbatchnumb>
        <drugauthorizationnumb>21920</drugauthorizationnumb>
        <drugdosagetext>220 MG, PRN, ORAL, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>244297C</drugbatchnumb>
        <drugauthorizationnumb>21920</drugauthorizationnumb>
        <drugdosagetext>220 MG, PRN, ORAL, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517842-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MESA-2007-037</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugauthorizationnumb>21252</drugauthorizationnumb>
        <drugdosagetext>1000MG, QD,</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517843-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07100945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, X21 DAYS, THE OFF X7 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517844-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05698-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517845-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05772-01</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>117.028</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugdosagetext>460 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517846-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07101278</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>DOSE RANGE FROM 200-400 MG QD, ORAL; 200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>DOSE RANGE FROM 200-400 MG QD, ORAL; 200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517847-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07091397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>QHS, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>QHS, ORAL; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517848-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05753-01</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOTHAL</medicinalproduct>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>70/30 NPH / REGULAR INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517849-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05717-02</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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOSYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517850-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S07-USA-05821-01</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>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>100 MG BID</drugdosagetext>
        <drugindication>HYPERSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>100 MG QD</drugdosagetext>
        <drugindication>HYPERSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517851-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ELI_LILLY_AND_COMPANY-PT200710000031</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugbatchnumb>A341129, A283195</drugbatchnumb>
        <drugdosagetext>910 UG, EVERY THREE WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>362.5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>362.50 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517852-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-07P-087-0376686-00</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517853-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-US251212</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517854-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18305</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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEMOLINE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517855-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE18753</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517856-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007S1010600</companynumb>
    <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>75945</drugauthorizationnumb>
        <drugdosagetext>80 MG; TWICE A DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>80 MG; TWICE A DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517857-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ISPH-2007-0020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugauthorizationnumb>50810</drugauthorizationnumb>
        <drugdosagetext>1GTT, TID, OPTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIBROM (BROMFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECONOPRED (PREDNISOLONE ACETATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517858-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-06090216</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY FOR 20 DAYS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMOL (ANTIARRHYTHMICS, CLASS I AND III)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (CENTRUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517859-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07091508</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517860-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07090352</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517861-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07021133</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517862-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-07110292</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517863-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-21880-07101459</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL; 10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOETIN(EPOETIN ALFA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517864-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>07082197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75657</drugauthorizationnumb>
        <drugdosagetext>5MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSKI (POTASSIUM IODIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVASIN (ISOSORBIDE DINITRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517865-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022534</companynumb>
    <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>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517866-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04756</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE(LISDEXAMFETAMINE DIMESYLATE) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21977</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517867-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04755</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>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>21977</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517868-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IMP_03057_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION 300 MG (NOT SPECIFIED)</medicinalproduct>
        <drugauthorizationnumb>77415</drugauthorizationnumb>
        <drugdosagetext>(300 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517869-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>070132</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALFLYTELY</medicinalproduct>
        <drugbatchnumb>1907024</drugbatchnumb>
        <drugauthorizationnumb>21551</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517870-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IMP_03107_2007</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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDEPRION 150 MG (NOT SPECIFIED)</medicinalproduct>
        <drugauthorizationnumb>75913</drugauthorizationnumb>
        <drugdosagetext>(150 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517871-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007P1000683</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>40</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL GANGLION DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFEX</medicinalproduct>
        <drugauthorizationnumb>20954</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>L006474</drugbatchnumb>
        <drugdosagetext>0.4 MG/KG;X1;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC PNEUMONIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFIBROTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRILAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTOMENADIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517872-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163056USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>END-TIDAL CO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>75102</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517873-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_00990_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.2669</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE/RIBAVIRIN/THREE RIVERS PHARMA 200 MG (ALFA-2B/SCHERING-PLOU</medicinalproduct>
        <drugbatchnumb>A21331</drugbatchnumb>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>(400 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>(64 UG 1X/WEEK SUBCUTANEOUS)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>(200 TABLETS OVER 30 DAYS OR SO ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517874-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>21067</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517875-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP020893</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>129.7287</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517876-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163774USA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>77523</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517877-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>161839USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</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>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>(20 MG), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517878-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022975</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>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023349</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>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517880-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-03461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPIFARNIB(TIPIFARNIB) ORAL DRUG UNSPECIFIED FORM</medicinalproduct>
        <drugdosagetext>600.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517881-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007VX001435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASMAR</medicinalproduct>
        <drugauthorizationnumb>20697</drugauthorizationnumb>
        <drugdosagetext>TID;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA-CARBIDOPA IR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA-CARBIDOPA CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517882-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN (INSULIN HUMAN INJECTION, ISOPHANE, INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS (CALCIUM, VITAMIN D NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517883-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517884-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006US001020</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>9 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>2.5 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPIN (FELODIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE (HYDRALAZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517885-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002751</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>RENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>25 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517886-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002454</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>25 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517887-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163056USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VENTRICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>75102</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517888-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI006637</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>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN OVARIAN TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517889-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023397</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>BIOPSY LYMPH GLAND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32024</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517890-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI016681</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>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517891-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023519</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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517892-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023521</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>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517893-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019985</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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68023</drugbatchnumb>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517894-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI019623</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>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517895-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI018344</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>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517896-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022958</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517897-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022888</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <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>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517898-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023467</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>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517899-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023514</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517900-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023642</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517901-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI023644</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>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517902-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI018675</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>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL GROWTH FACTOR RECEPTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35084</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517903-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2006BI012227</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35068</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35074</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P35098</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517904-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020421</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517905-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000484</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>21438</drugauthorizationnumb>
        <drugdosagetext>40 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517906-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US09343</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>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>84176</drugauthorizationnumb>
        <drugdosagetext>50 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>20, MG, BOLUS; INTRAVENOUS, 40 MG, BOLUS; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>50 MG,   INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517907-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007US09162</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEST NILE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>65017</drugauthorizationnumb>
        <drugdosagetext>100MG, QD;</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>750 MG, BID;, 250 MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG,QD;</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB(DACLIZUMAB)</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517908-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000484</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>21438</drugauthorizationnumb>
        <drugdosagetext>40 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517909-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>017005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRACEPTIVE DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL; 20 MG, TID, ORAL;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD, ORAL; 20 MG, TID, ORAL;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517910-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#1#2007-00276</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugdosagetext>2MG/24H, 1 IN 1, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517911-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430015K07USA</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>BARTHOLIN'S ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY COMMON VARIABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED, NOT REPORTED, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE(IMIPRAMINE/0005901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALTREXONE(NALTREXONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517912-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI017069</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMINGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517913-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>154R003K IN-111ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugbatchnumb>156R002K Y-90 ZEVALIN</drugbatchnumb>
        <drugdosagetext>1X;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517914-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI022793</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>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugdosagetext>300 MG;QM;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517915-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007BI021767</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESENILE DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATALIZUMAB</medicinalproduct>
        <drugbatchnumb>P68026</drugbatchnumb>
        <drugdosagetext>300 MG; QM; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517916-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP07000961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D /00944201/ (COLECALCIFEROL, CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517917-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022572</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>; QW;</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG; QD;</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517918-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>016393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE BEFORE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76135</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070131</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517919-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>020485</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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517920-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AVENTIS-200719390GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RPR 109881A</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>FREQUENCY: CYCLICALLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREOFLAT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517921-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200720274GDDC</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>102.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFLIBERCEPT</medicinalproduct>
        <drugbatchnumb>C04008M600B11</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMYXOMA PERITONEI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517922-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071108</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>07-001526</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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugauthorizationnumb>21852</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517923-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0706USA04912</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>78.9259</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugbatchnumb>U4845</drugbatchnumb>
        <drugauthorizationnumb>22044</drugauthorizationnumb>
        <drugdosagetext>500MG/50 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517924-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0707USA01128</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>105.6881</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>22044</drugauthorizationnumb>
        <drugdosagetext>500 MG/50 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517925-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0708USA02922</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>60 MG/HS/PO ; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517926-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0707USA03495</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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>20-40 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517927-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0705USA04915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG/TID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPY UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517928-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0705USA00647</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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517929-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0705USA00841</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAILY/PO 40 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>20 MG/DAILY/PO 40 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISALCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517930-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>WAES 0704USA04220</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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugauthorizationnumb>19643</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517931-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071107</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>17646</companynumb>
    <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-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76517</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517932-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517933-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>6E655</drugbatchnumb>
        <drugdosagetext>ONE TABLET Q 4 -6 HRS PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>2E225</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>3C363</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517934-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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 ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATE-P</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517935-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL DECOMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETROPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CYST EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>1.25MG/2.5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>2.5MG/0.625MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MPA</medicinalproduct>
        <drugdosagetext>10MG/5MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ATROPHIC VULVOVAGINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVCON-35</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517936-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US04066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.829</patientweight>
      <patientsex>2</patientsex>
      <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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS BRACHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625MG/2.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>EZ DIAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000418</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625MG/2.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625MG/5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
        <drugtreatmentduration>436</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
        <drugdosagetext>0.625MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950811</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3MG QD</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA /USA/</medicinalproduct>
        <drugdosagetext>240MG UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>10MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>240MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>.05MG</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>10MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>350MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.05MG UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517937-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ETHMOID SINUS SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ANTROSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>0.05MG</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030711</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021219</drugenddate>
        <drugtreatmentduration>1351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020411</drugenddate>
        <drugtreatmentduration>400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>0.05 MG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030719</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960216</drugenddate>
        <drugtreatmentduration>575</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 50/50</medicinalproduct>
        <drugdosagetext>70/30; 30UAM, 30UPM</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugdosagetext>250MG</drugdosagetext>
        <drugindication>MALARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>20MG/500MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>83MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugdosagetext>2MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517938-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006NL10884</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOSYNCRATIC DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1375 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517939-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP18275</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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517940-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US10700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90MG UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1800 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300MG UNK</drugdosagetext>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>25MCG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>80MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4MG 4 DAYS EACH MONTH</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517941-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugbatchnumb>201653</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517942-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP10943</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>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517943-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007FI16692</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTELOS</medicinalproduct>
        <drugdosagetext>2 G/DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTOL</medicinalproduct>
        <drugdosagetext>200 TO 800 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517944-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007SE16115</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPLORATIVE LAPAROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517945-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17749</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <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>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>4.5 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FP</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>7.0 TO 10.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugdosagetext>3.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>1233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517946-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>20 MG/KG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517947-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIKELAN (NVO)</medicinalproduct>
        <drugauthorizationnumb>19972</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OCULAR HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYALURONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAZOCHROME SODIUM SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517948-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>MITRAL VALVE INCOMPETENCE</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>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517949-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE18396</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LBH589</medicinalproduct>
        <drugdosagetext>80 MG QD M/W/F</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517950-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US06681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.142</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMUSCULAR DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>21200</drugauthorizationnumb>
        <drugdosagetext>6MG QD TO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070407</drugenddate>
        <drugtreatmentduration>1649</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR MDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>500 UNK, PRN</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160/12.5 QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNK, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517951-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US09207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST COSMETIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MODIFIED RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>0.05 MG TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970304</drugenddate>
        <drugtreatmentduration>1293</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MPA</medicinalproduct>
        <drugdosagetext>UNK, QD ONE TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK, QD, ONE TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930820</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugdosagetext>.625/5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990310</drugenddate>
        <drugtreatmentduration>1063</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>UNK, QHS TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.625 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.6 UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
        <drugtreatmentduration>1062</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES NOS</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517952-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMLIN</medicinalproduct>
        <drugdosagetext>60 MCG BEFORE MEALS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517953-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14101</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517954-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US11703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugauthorizationnumb>021200</drugauthorizationnumb>
        <drugdosagetext>6MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>CASUAL USE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/20 MG QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>4MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>100MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>450MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugdosagetext>500MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517955-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US09204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>19081</drugauthorizationnumb>
        <drugdosagetext>0.1MG</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10MG UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MPA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625MG/2.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981021</drugenddate>
        <drugtreatmentduration>269</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>.625MG/5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001019</drugenddate>
        <drugtreatmentduration>704</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20MG UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>10MG QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517956-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BREAST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY DYSMORPHIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOLICHOCOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT BREAST LUMP REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOTHERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugauthorizationnumb>019081</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
        <drugtreatmentduration>430</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517957-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>1000</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1400MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517958-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB02393</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IN VITRO FERTILISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERM COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA PROGRESSIVE MOTILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL RETARD</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL RETARD</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517959-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007CA08683</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMN107</medicinalproduct>
        <drugauthorizationnumb>22068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070518</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODUR II</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517960-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517961-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007CO18768</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</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>CHOLURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517962-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18855</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOID OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>320 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517963-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03697</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517964-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517965-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE18775</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>160/5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTICOAGULANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517966-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517967-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US13145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>20665</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517968-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US12298</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>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND EVISCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050715</drugauthorizationnumb>
        <drugdosagetext>200 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517969-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2006GB03365</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>700MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517970-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007BE17758</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>050737</drugauthorizationnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517971-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BE17011</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 4 WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECAPEPTYL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>11.25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517972-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2007CA01623</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>1.5MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070410</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517973-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>STARTED 37.5 WENT SLOW TO 425MG ONE A DAY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517974-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>21 UNITS EVERY TWO WEEKS INTRACARDIA</drugdosagetext>
        <drugadministrationroute>016</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517975-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10MG TABS PACK 48'S PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>5MG TABLETS PACK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517976-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG 1/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE FEVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugbatchnumb>63622</drugbatchnumb>
        <drugdosagetext>500MG THREE TIMES DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517978-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517979-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIC RAMI FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150MG EVERY MONTH PO; 2 DOSES SEVERE BONE PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>ACTONEL EVERY WEEK PO, ALMOST 2 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517981-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>060044K07USA</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPHENE</medicinalproduct>
        <drugauthorizationnumb>18361</drugauthorizationnumb>
        <drugindication>INFERTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN CHORIONIC GONADOTROPIN           (CHORIONIC GONADOTROPHIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517982-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238491K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517983-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239459K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIABETICS (ORAL ANTIDIABETES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517984-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239402K07USA</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>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517985-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239118K07USA</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE       (MELCLOZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235086K06USA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                             (COTYLENOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE                        (RAMIPRIL /00885601/)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN                             (METFORMIN /00082701/)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238938K07USA</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>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                          (COTYLENOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC                   (ANTIBIOTICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>237444K07USA</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>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>237685K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517990-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>239405K07USA</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>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517991-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>238382K07USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517992-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430037M07USA</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517993-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>75 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517994-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12255</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>50 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517995-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12244</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>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>70 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517996-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_30818_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>DF ORAL,  DR ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>DF ORAL,  DR ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517997-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AP07-010</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>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>76003</drugauthorizationnumb>
        <drugdosagetext>100MG Q.I.D. ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>76003</drugauthorizationnumb>
        <drugdosagetext>100MG Q.I.D. ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517998-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-13980289</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>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugauthorizationnumb>020972</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5517999-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01733_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugauthorizationnumb>21778</drugauthorizationnumb>
        <drugdosagetext>(650 MG BID ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE ES</medicinalproduct>
        <drugdosagetext>(625 MG QD ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518000-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAR_01770_2007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>70481</drugauthorizationnumb>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>TENDONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>(1760 MG IN THE AFTERNOON; ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>(DF)</drugdosagetext>
        <drugindication>TENDONITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518001-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007PO0160</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>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518002-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022426</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>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518003-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-13980255</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518004-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-13977277</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BURKITT'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518005-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-13980230</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>2MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518006-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13978952</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>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ADMINISTERED OVER 1 HOUR ON DAY 1 FROM 02-OCT-2007 -20-OCT-2007, CYCLE 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>ADMINISTERED OVER 1HR,ON DAYS 1-3, CYCLE 3 FROM 02-OCT-2007-04-OCT-2007.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON DAYS 1-14 FROM 02-OCT-2007-07-OCT-2007, CYCLE 3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518007-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18664</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>1 TABLET IN THE MORNING, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugbatchnumb>Z0041A</drugbatchnumb>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518008-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200700684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>0.75 MG/KG, BOLUS, IV BOLUS; 1.75 MG/KG, HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518009-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US021597</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>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>1.5 MG/KG QD INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR /01362601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518010-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007KR18516</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518011-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18713</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISPHONAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518012-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14554</companynumb>
    <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 STAGE I</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPETIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugauthorizationnumb>020364</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518013-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18710</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518014-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007US17851</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>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN REDUCTION OF FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4MG EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <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>20030820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03302</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN (NGX)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>TINEA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA CRURIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071008</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007DE18519</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>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOMACK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-06P-127-0326353-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYPTOSPORIDIOSIS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</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>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP021047</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>6-CO-4003</drugbatchnumb>
        <drugdosagetext>30 MCG; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugbatchnumb>6RCJ037</drugbatchnumb>
        <drugdosagetext>600 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>P092190</drugbatchnumb>
        <drugdosagetext>40000 IU; QW; SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUALAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>100MG  5XDAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2007A06000</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>19943</drugauthorizationnumb>
        <drugdosagetext>1.88 MG (1.88 MG, 1 IN 28 D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TYCO HEALTHCARE/MALLINCKRODT-T200701326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK IN PLASTIC SYRINGES</medicinalproduct>
        <drugbatchnumb>M216B</drugbatchnumb>
        <drugauthorizationnumb>20937</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518024-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-166751-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>67.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518025-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-167087-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518026-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-266437</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>TW502281</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>62 IE, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070618</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>95 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518027-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-267495</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518028-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-268880</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-INSULIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518029-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-268996</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR FLEXPEN</medicinalproduct>
        <drugauthorizationnumb>21536</drugauthorizationnumb>
        <drugdosagetext>12 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERX SOLUTION 2.6 MG/STRIP</medicinalproduct>
        <drugdosagetext>56 IU, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>273</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRINE                           /00002701/</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN-S</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACOMBI                         /00045401/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518030-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-267474</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>3 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRAUMATIC HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCURON</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINA                           /00171201/</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLINA</medicinalproduct>
        <drugdosagetext>17 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPNOVEL                            /00634101/</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMICINA                        /00304201/</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMICINA                       /00166002/</medicinalproduct>
        <drugdosagetext>5 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugdosagetext>SELECTIVE DIGESTIVE DECONTAMINATION</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERREM                             /01250501/</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINA                           /01223201/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>3G/24 HR CONTINUES INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAPENEMS</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGECYCLINE</medicinalproduct>
        <drugdosagetext>50 UNK, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACINETOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERONEM                            /01250501/</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070923</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPHENICOL</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugdosagetext>6000 IE, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 UNK, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTROMYCIN</medicinalproduct>
        <drugdosagetext>250 UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTRINGENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518031-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM</medicinalproduct>
        <drugindication>COMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060324</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518032-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00582107</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>4000 IU PER INJECTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518033-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00576707</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTES MATURATION ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>ONE SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEETHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAFLUOR</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 RECTAL CAPSULE ON 01-OCT-2007 AND 2 RECTAL CAPSULES ON 04-OCT-2007</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518034-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BRISTOL-MYERS SQUIBB COMPANY-13976386</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518035-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-13980578</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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>RECEIVED ON 11MAY06.CETUXIMAB-2 MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518036-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13359104</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NON-CURRENT DRUGS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518037-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>56.246</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSTILLATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE PURE TEARS SINGLE-DROP   GLYCERIN 0.2%, HYPROM 0.2%, ETC  PHIZE</medicinalproduct>
        <drugbatchnumb>004057</drugbatchnumb>
        <drugdosagetext>1 - 2 DROPS IN AFFECTED EYE[S] AS NEEDED  INTRAOCULAR</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518038-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>TAKE ONE TWICE DAILY  AM AND PM  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060726</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518039-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNWANTED AWARENESS DURING ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>8MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714410BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711224BVD</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-200711344GDS</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL</medicinalproduct>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVERSAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINELON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBREX</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 0.3 %</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070321</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFINITRINA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMORRANE 1%</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714406BWH</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-200716078GDS</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugbatchnumb>173266</drugbatchnumb>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG  UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH MEDICINE NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20071007293</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CRYPTOSPORIDIOSIS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROMOMICINA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CRYPTOSPORIDIOSIS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071102604</companynumb>
    <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>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>1500 TO 3000MG DAILY</drugdosagetext>
        <drugindication>SCIATICA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071103723</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>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR200711001445</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>40 UNK, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>35 UNK, EACH EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518050-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13766803</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>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>STOPPED ON 22-APR-07, RESTARTED 2-MAY-07</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugdosagetext>STOPPED ON 22-APR-07, RESTARTED 2-MAY-07</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518051-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100MG  2 X DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518052-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>ONE HALF PILL  TWICE A DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518053-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071007223</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugauthorizationnumb>19813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TOSUFLOXACIN TOSILATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518054-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-166559-NL</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOCAL NODULAR HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVELLE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518055-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-167078-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>15 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYLPENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518056-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20071002175</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.5-1-1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMINAL</medicinalproduct>
        <drugdosagetext>40 MG TABLETS 1.5-1-1.5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMINAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518057-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20060204962</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518058-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070902849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518062-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071004527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.08</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE PATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518063-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070104699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518064-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070900752</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>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTESTINAL PERFORATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518065-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518066-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-BAXTER-2007BH008615</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12G038AK</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518067-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2007A05419</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG (11.25 MG,1 IN 12 WK)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4 (PROPIVERINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP PATCH (FENTANYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK (OLOPATADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA ALEXANDRINA LEAF)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518068-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001245</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>78199</drugauthorizationnumb>
        <drugdosagetext>250 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070926</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518069-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709005543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A327071</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518070-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709000204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</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>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518071-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200710005551</companynumb>
    <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>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000392</companynumb>
    <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A327071</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200711001454</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>800 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>120 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>30 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>2556</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>2 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070810</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC G</medicinalproduct>
        <drugdosagetext>500 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC G</medicinalproduct>
        <drugdosagetext>2000 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC G</medicinalproduct>
        <drugdosagetext>500 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 3A</medicinalproduct>
        <drugdosagetext>500 ML, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070814</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200708000538</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</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>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070719</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A311441</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU200710007592</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, DAY 1 EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200707001194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.793</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>715 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>5 D/F, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070630</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 UG, OTHER</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000206</companynumb>
    <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>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF6H10A</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-USA030125488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.091</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE PHOSPHATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>HIP FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3J95A</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>40 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>40 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
        <drugdosagetext>600 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD-LIVER OIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANGANESE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA200711000761</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>400 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070416</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070812</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>*SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>25 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518081-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001269</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>78199</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE (CARBIMAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518082-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008829</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>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPN</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518083-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AP001263</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>76882</drugauthorizationnumb>
        <drugdosagetext>125 MG;QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518084-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES18734</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18773</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARFORM</medicinalproduct>
        <drugauthorizationnumb>21204</drugauthorizationnumb>
        <drugdosagetext>120MG NATEGLINIDE/500 MG METFORMIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARFORM</medicinalproduct>
        <drugauthorizationnumb>021204</drugauthorizationnumb>
        <drugdosagetext>60MG NATEGLINIDE, 500 MG METFORMIN</drugdosagetext>
        <drugtreatmentduration>86400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518086-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18892</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT18609</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50574</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>3 G/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CANRENOATE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18622</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL HORMONE PREPARATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14611</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007BR18682</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC LAVAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>200 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518091-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20070506223</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <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>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2 DF QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518092-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-JNJFOC-20071102091</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR SEMINOMA (PURE) STAGE II</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ASTRAZENECA-2007AC02145</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518094-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2007BH008892</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD LIQUID</medicinalproduct>
        <drugbatchnumb>LE12G075AD</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518095-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>150871ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL LEUKOPLAKIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugauthorizationnumb>73671</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG,1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061003</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518096-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163506ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugauthorizationnumb>18679</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG,2 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518097-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-164577-NL</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION NEUROLOGICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>6 MG ONCE/NI/8 MG ONCE; INTRAVENOUS BOLUS/INTRAVENOUS DRIP/INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518098-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007-162795-NL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </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>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARVELON</medicinalproduct>
        <drugauthorizationnumb>20071</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060309</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518099-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200714457BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518100-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007ES18734</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518101-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101952</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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518102-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20070902677</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <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>7 INFUSIONS ON UNSPECIFIED DATES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518103-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20071006175</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELIFEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071102356</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CROMOGLYCATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-200711000BVD</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>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-BAXTER-2007BH008344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </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>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04508</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>63187</drugauthorizationnumb>
        <drugdosagetext>2 X 100 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA PRIMARY ATYPICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROLOC (PANTOPRAZOLE) (TABLETS) (PANTOPRAZOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPOCET (PARACETAMOL) (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN (DICLOFENAC POTASSIUM) (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518109-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04500</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugauthorizationnumb>77299</drugauthorizationnumb>
        <drugdosagetext>125 MG (CURRENT DOSE) AT THE AGE OF 12</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6039115</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>2,5 MG (2,5 MG, 1 IN 1D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070503</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6039142</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>0,5 DOSAGE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL  (URAPIDIL)</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS (2 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS (2 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS (2 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS (1 DOSAGE FORMS, 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARGECIC (160 MG, POWDER FOR ORAL SOLUTION) (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON (12,5 MG, TABLET) (TIANEPTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518112-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518113-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>13972633</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVIA</medicinalproduct>
        <drugauthorizationnumb>18932</drugauthorizationnumb>
        <drugdosagetext>50 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADON HCL TAB</medicinalproduct>
        <drugdosagetext>120 MILLIGRAM 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>10  MILLIGRAM 1 DAY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AOTAL (ACAMPROSATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE (CLORAZEPATGE DIPOTASSIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518114-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>100#03#2007-04515</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>75982</drugauthorizationnumb>
        <drugdosagetext>100 MG FOUR TIMES A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070907</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3 (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONIC ACID (ALENDRONIC ACID) (ALENDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL (PARACETAMOL) (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE) (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518115-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB 250MG/M2</medicinalproduct>
        <drugdosagetext>432MG 8 WEEK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>325MG QWK X 3 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001#1#2007-00500</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>18484</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-1164329</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR HOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugauthorizationnumb>21257</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2007GB03284</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>RETAINED PLACENTA OR MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOMETRINE</medicinalproduct>
        <drugauthorizationnumb>6035</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>3 DOSES (IV)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518120-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20070703017</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20071102793</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518122-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugdosagetext>1 TAB BY MOUTH EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518124-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.9</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>750MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518125-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713513FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET                            /00731801/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200720349GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20743</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GIARDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEMETIL                           /00013301/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugdosagetext>250MG DAILY SEVERAL DAYS</drugdosagetext>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518128-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AVENTIS-200720358GDDC</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugauthorizationnumb>020743</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518129-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712165JP</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>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070606</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN                            /00013301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL                             /01178101/</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENA</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518130-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200712595JP</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>51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugdosagetext>DOSE: {40</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOSENN                            /00476901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL                         /00056201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL                             /01178101/</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518131-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200710626JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518132-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE890111SEP06</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>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021821</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060906</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE/SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG EVERY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G IF NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG EVERY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060906</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518133-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WYE-H00588707</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>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518134-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>BYETTA 10MCG AT BREAKFAST AND SUPPER SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518135-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STI-2007-01802</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>CLINDOXYL GEL            (CLINDAMYCIN + BENZOYL PEROXIDE)</medicinalproduct>
        <drugauthorizationnumb>50741</drugauthorizationnumb>
        <drugdosagetext>FACE AND BREAST</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDESLEUKIN</medicinalproduct>
        <drugdosagetext>77.76 MILLION UNITS EVERY 8 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(AVASTIN)-GENENTECH, INC</medicinalproduct>
        <drugbatchnumb>SEE ATTACHED EMAIL</drugbatchnumb>
        <drugdosagetext>10MG/1 D KG DAYS 1, 15</drugdosagetext>
        <drugindication>OVARIAN CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(AVASTIN)-GENENTECH, INC</medicinalproduct>
        <drugbatchnumb>SEE ATTACHED EMAIL</drugbatchnumb>
        <drugdosagetext>10MG/1 D KG DAYS 1, 15</drugdosagetext>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugbatchnumb>SEE ATTACHED EMAIL</drugbatchnumb>
        <drugdosagetext>4MG/M2 DAYS 1, 8,15</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBOPOETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRILAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20071101988</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518139-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.0698</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE CR</medicinalproduct>
        <drugdosagetext>40MG ONE P.O. TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE CR</medicinalproduct>
        <drugdosagetext>40MG ONE P.O. TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLANK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugdosagetext>20MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MHRA ADR NO: ADR20177377-001</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugauthorizationnumb>20439</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163840USA</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE             (PIMOZIDE)</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METPORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMOPRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
        <drugdosagetext>2 TABS QID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5MG  BID  ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2005A04609</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSAP 400</medicinalproduct>
        <drugauthorizationnumb>50757</drugauthorizationnumb>
        <drugdosagetext>1 CARD (0.5 CARD, 2 IN 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct> KETAS (IBUDILAST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENERIC OXYCODONE ER 40 MG</medicinalproduct>
        <drugdosagetext>4 TAB BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENERIC OXYCODONE ER  20 MG</medicinalproduct>
        <drugdosagetext>2 TAB BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG  1 1/2   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163842USA</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE                   (PIMOZIDE)</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE                   (PIMOZIDE)</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>99586</drugbatchnumb>
        <drugdosagetext>ONE BID ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>99586</drugbatchnumb>
        <drugdosagetext>ONE BID ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSAMIN DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.6266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518155-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713372BWH</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070912</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713516FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518157-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2007DE03793</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>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518158-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007IT18707</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
        <drugtreatmentduration>884</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG/5 ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-EFFERALGAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518159-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600MG TID MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518160-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518161-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0558</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</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>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>759</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN 30%/ISOPHANE INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ASCORBATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMMA-LINOLENIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIELURIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugdosagetext>PRIOR TO ADMISSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0661</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>EXTRAMEDULLARY HAEMOPOIESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG/100, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070214</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG/100, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.0698</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>5 MCG SQ BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518165-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientweight>88.905</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugbatchnumb>TTC7007B</drugbatchnumb>
        <drugdosagetext>500MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-07-0694</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>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM DOBESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTEMISIA ASIATTCA 95% ETHANOL EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>5 MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518169-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00588907</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071101576</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>
      <patientweight>81.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIDRADENITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20071102966</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518173-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070905676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20070605625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL248593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-US207116</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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>FLUSHES,   IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518178-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>7 MG  1/DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518179-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GRT-2007-13399</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>
      <patientweight>132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>20612</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HELICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFONILUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULODEXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYLIODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>ONE CAPSULE  DAILY</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</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>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004690</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>75694</drugauthorizationnumb>
        <drugdosagetext>600 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>CLONAZEPAM 2MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518184-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL250006</companynumb>
    <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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P099846</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-US247391</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518186-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL251097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518187-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientweight>45.8133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>N77070</drugbatchnumb>
        <drugdosagetext>750 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518188-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004688</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>75694</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518190-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2.0MG IVP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>100MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>750MG/M2</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN</medicinalproduct>
        <drugdosagetext>50MG/M2</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518191-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugdosagetext>20 MG QAM TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYTRANA</medicinalproduct>
        <drugdosagetext>20 MG QAM TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518192-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004686</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>75690</drugauthorizationnumb>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>10MCG BID SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518194-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX251084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US251944</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED 25 MG 2 PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>PREFILLED SYRINGE 50 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>LYOPHILIZED (DOSE AND FRECUENCY UNKNOWN)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>14640 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE HCL</medicinalproduct>
        <drugdosagetext>88 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004683</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>75690</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1785 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB(MOAB C2B8 ANTI CD20, CHIMERIC)</medicinalproduct>
        <drugdosagetext>890 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518199-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200713481BWH</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>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>TOTAL DAILY DOSE: 800 MG  UNIT DOSE: 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
        <drugtreatmentduration>41</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>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 225 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 225 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19570101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX249727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-US244275</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518202-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ASTRAZENECA-2007SE05281</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20196</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>NEUROMUSCULAR BLOCKADE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugbatchnumb>STRUCTURE DOSAGE NUMBER 1.5 MG</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEDRIN</medicinalproduct>
        <drugdosagetext>STRUCTURE DOSAGE NUMBER 50 MG</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518203-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP07202</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ASTRAZENECA-2007AP07201</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>755</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>21929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOSPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCORONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCORONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2007AP07208</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP17946</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIKELAN (NVO)</medicinalproduct>
        <drugauthorizationnumb>19972</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>OCULAR HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM HYALURONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAZOCHROME SODIUM SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID STIMULATING HORMONE-PRODUCING PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID STIMULATING HORMONE-PRODUCING PITUITARY TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH200711002218</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOID PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOID PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711002446</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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518210-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB200711002483</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPIXOL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>10 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518211-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-13589486</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SORAFENIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061115</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518212-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-13978986</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>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250122</companynumb>
    <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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 GTT, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-248414</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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200713481FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugauthorizationnumb>21144</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX                             /00058402/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPODERM                          /00008701/</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GENENTECH-245842</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>#B3070/ #B3068</drugbatchnumb>
        <drugdosagetext>1065 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>304.5 MG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070920</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROXIZINA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMSYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2007UW25969</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugauthorizationnumb>021513</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP06548</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20168</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>021399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOFEED</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070911</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YODEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASEA</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINE HCL</medicinalproduct>
        <drugindication>THORACIC CAVITY DRAINAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518220-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688856A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693741A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518222-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694620A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>018612</drugauthorizationnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518223-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694639A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518224-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0455243A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICABATE CQ 21MG</medicinalproduct>
        <drugbatchnumb>0604943A</drugbatchnumb>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>1PAT PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070110</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494824A</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>21887</drugauthorizationnumb>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INVESTIGATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugdosagetext>30MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>ANALGESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCODAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495217A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ CLEAR 14MG</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN CQ 2MG LOZENGE</medicinalproduct>
        <drugauthorizationnumb>021330</drugauthorizationnumb>
        <drugdosagetext>5LOZ PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>10904, 10914</drugbatchnumb>
        <drugdosagetext>1065 UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>10904, 10914</drugbatchnumb>
        <drugdosagetext>1065 UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PACLITAXEL</medicinalproduct>
        <drugbatchnumb>10904, 10914</drugbatchnumb>
        <drugdosagetext>1065 UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PLACEBO</medicinalproduct>
        <drugbatchnumb>10904, 10914</drugbatchnumb>
        <drugdosagetext>1065 UNK, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>88 NG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518228-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-13974951</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIGON-DEPOT</medicinalproduct>
        <drugauthorizationnumb>14901</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518229-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-13878285</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>5MG ON 25JUN07; 10MG DAILY ON 02JUL07; 15MG 12JUL07; 20MG 19JUL07 TO 02AUG07.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518230-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13976584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518231-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-13980750</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>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>18057</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PEMETREXED DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GENENTECH-250826</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK, 1/MONTH</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, Q2M</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENENTECH-250857</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>375 MG, 2/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, 2/WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>44 IU, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518234-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GENENTECH-251048</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SY-GENENTECH-251227</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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
        <drugdosagetext>12 UNK, UNK</drugdosagetext>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518236-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>22400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>3360 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>4200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>11200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518237-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0626410A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTIGMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAMPTODACTYLY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOGENETIC ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROGNATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL SALT-WASTING SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WILLIAMS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN AC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518238-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0630322A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPLASTIC LEFT HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518239-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0640665A</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>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</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>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERRUPTION OF AORTIC ARCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATALCARE PLUS</medicinalproduct>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL COLD</medicinalproduct>
        <drugdosagetext>2CAP AS REQUIRED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2CAP AS REQUIRED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0662267A</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>97.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugauthorizationnumb>022012</drugauthorizationnumb>
        <drugdosagetext>80MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0668357A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMLINTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518242-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0668655A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</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>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0676057A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
        <drugauthorizationnumb>012342</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0676441A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0687709A</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>EXTERNAL EAR CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>72MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518246-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0688504A</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>92.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0690325A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNAVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518248-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693592A</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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518249-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693606A</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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518250-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0693937A</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>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>R302604</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518251-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694603A</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518252-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694791A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518253-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0694797A</companynumb>
    <primarysource>
      <reportercountry>CANADA</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 ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518254-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0482241A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>KN 6694</drugbatchnumb>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518255-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0483797A</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>47.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>20089</drugauthorizationnumb>
        <drugdosagetext>200MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070813</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOL-MELCORT</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070807</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL CIRCULATORY FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>.75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518256-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0484091A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070811</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>125MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZHEXOL</medicinalproduct>
        <drugdosagetext>2MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518257-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0490666A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518258-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491143A</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>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>21345</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070722</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugdosagetext>.5G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070914</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070919</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518259-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491452A</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>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAKEPRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518260-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491760A</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>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071013</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518261-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0491768A</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</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>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>U PAN</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>120MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>15MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS OBLITERANS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518262-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0492755A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>21319</drugauthorizationnumb>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518263-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493090A</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>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON STEROIDAL ANTI-INFLAMMATORY DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN-CONVERTING ENZYME INHIBITOR (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518264-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493309A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518265-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493510A</companynumb>
    <primarysource>
      <reportercountry>ZIMBABWE</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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugauthorizationnumb>020857</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>960MG PER DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>30MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518266-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0493573A</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>4IU PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518267-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494120A</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>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>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518268-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494563A</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494699A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494700A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</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>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL S</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>330MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494884A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0494935A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518273-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495035A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070322</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518274-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495076A</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>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</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>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518275-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495194A</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518276-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495196A</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518277-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495202A</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>22059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1325MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518278-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495225A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>020405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</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>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518279-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495231A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME SODIUM</medicinalproduct>
        <drugbatchnumb>6011 LOT NUMBER</drugbatchnumb>
        <drugauthorizationnumb>050558</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070921</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518280-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495287A</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>ATRIAL FIBRILLATION</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>20071026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518281-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495314A</companynumb>
    <primarysource>
      <reportercountry>EGYPT</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 REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugauthorizationnumb>50578</drugauthorizationnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495425A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518283-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0495526A</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0054818A</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>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELONTRIL</medicinalproduct>
        <drugauthorizationnumb>21515</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>6DROP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIOFOR</medicinalproduct>
        <drugdosagetext>850MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518285-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AVENTIS-200718983GDDC</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518286-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-AVENTIS-200718968GDDC</companynumb>
    <primarysource>
      <reportercountry>NORWAY</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>N004</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSUMAN RAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN                          /00042901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518287-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200601001086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, EACH EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>0.15 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, 4/W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, 5/W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051018</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /USA/</medicinalproduct>
        <drugdosagetext>1000 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, 3/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.2 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>1000 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>1 D/F, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518288-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG /0.8 ML EVERY OTHER WEEK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518289-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518290-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
        <drugdosagetext>360 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518291-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>433213</drugbatchnumb>
        <drugdosagetext>20MG QD X21D/ 28D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518292-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-JNJFOC-20071104872</companynumb>
    <primarysource>
      <reportercountry>SLOVAKIA (Slovak Republic)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518293-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2032</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>66MG DAY 1, DAY 8 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>1B005K</drugbatchnumb>
        <drugdosagetext>2.9MG DAY 1, DAY 8 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518294-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CZ-JNJFOC-20070904881</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518295-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007AL004681</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>75690</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518296-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>139</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1175MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1175MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>1175MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>294MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>294MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>294MG QOW IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518297-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (GENENTECH)</medicinalproduct>
        <drugdosagetext>958MG IV EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518298-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>TOPOTECAN</medicinalproduct>
        <drugdosagetext>3 MG/M2 D1,8,15 Q 21 D IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.6 MG/M2 D1,8,15 Q 21 D IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518299-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04797</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>405 (LANTHANUM CARBONATE) (405 (LANTHANUM CARBONATE)) CHEWABLE TABLET</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518300-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007RL000501</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>600 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518301-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007JP09385</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HCL</medicinalproduct>
        <drugauthorizationnumb>85966</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAPROTILINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILNACIPRAN                       (MILNACIPRAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518302-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PURDUE-GBR_2007_0003437</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>38</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518303-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518304-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugdosagetext>ONE PILL EVERY FEW DAYS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518305-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09421</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518306-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518307-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG BID PO  3.5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060907</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518308-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09413</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugauthorizationnumb>65079</drugauthorizationnumb>
        <drugdosagetext>EVERY 30 MINUTES, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>EYE INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugdosagetext>EVERY 30 MINUTES, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>EYE INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NETILMICIN SULFATE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugindication>EYE INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518309-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-247778</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CASTLEMAN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518310-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518311-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AVENTIS-200717832US</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518312-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AVENTIS-200715243EU</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDEX                             /00340101/</medicinalproduct>
        <drugauthorizationnumb>18538</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN                            /00376902/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINITRIN</medicinalproduct>
        <drugdosagetext>DOSE: 1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINITRIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518313-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AVENTIS-200713010JP</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>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>16273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>DOSE: 6000 TO 12000 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA                           /00023516/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN                            /00476901/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518314-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-251102</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518315-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>200 MG AM / PM</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>200 MG AM / PM</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518316-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>106.5953</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>104509</drugbatchnumb>
        <drugdosagetext>1 PILL TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09417</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>76189</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULPHATE            (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN V                        (PHENOXYMETHYLPRENICILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071114</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</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>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>97942</drugbatchnumb>
        <drugdosagetext>1 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09484</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</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>TRISOMY 18</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09427</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>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518321-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDUCATIONAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518322-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GENENTECH-251130</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</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>RAPTIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW26313</companynumb>
    <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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW25677</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UNDER 75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2007UW26044</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>2%</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORC VISION BLUE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIOCHOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5%</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVIODINE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYMAR</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW19642</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>
      <patientweight>109.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>TITRATED TO 300MG IN THREE WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIET PILLS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW21078</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>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070830</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1-2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070817</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>EVERY 2 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09392</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>77040</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>84.8226</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>1 TAB  3/DAY X 5 DAYS  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP016557</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>
      <patientweight>47.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>100 MG;QD;NGT</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>4 MG; ;NGT</drugdosagetext>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>2 GM;QD;NGT</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 GM; ;NGT</drugdosagetext>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>200 MG; ;NGT</drugdosagetext>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALFDIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>57.1532</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>N77070</drugbatchnumb>
        <drugdosagetext>650 MG  IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>THROMBOTIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518332-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG   1 TIME A DAY   PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>1 TABLET  BEDTIME  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-530311</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</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>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518335-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-468352</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY UNKNOWN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061030</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG WEEKLY PO  (DURATION: APPROXIMATELY 6 WKS PTA)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARGE GRANULAR LYMPHOCYTOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-530530</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>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>TRANSDERMAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-483202</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518339-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-512349</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518340-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG ALTERNATE WITH 80MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518341-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>N-ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518342-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CR-ROCHE-526136</companynumb>
    <primarysource>
      <reportercountry>COSTA RICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugauthorizationnumb>18662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518343-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-423646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</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>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518344-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-509521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.1</patientweight>
      <patientsex>2</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518345-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-527903</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518346-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-484621</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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>INTRA-ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>50758</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518347-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</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>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</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>19990929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING DOSE OF 40MG WITH AN UNKNOWN DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>11 CAPSULES PER WEEK.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518348-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-473702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</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>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518349-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503101</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>
      <patientweight>44.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 1-2-1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 1-2-1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-428836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROAT LOZENGES</medicinalproduct>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECONAMINE SR</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>DOSING REGIMEN EVERY 4-6 HRS PRN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDIUM</medicinalproduct>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROWASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN TID PRN.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFAK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS 2% GM.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRI-LEVLEN 28</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518351-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-530105</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518352-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-503440</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 INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSAGE REPORTED AS 2 200 MG TABLETS IN THE MORNING AND 3 TABLETS IN THE EVENING.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518353-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-512242</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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>FORM: PRE-FILLED SYRINGE, INDICATION: HEPATITIS C (GENOTYPE 4)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>INDICATION: HEPATITIS C (GENOTYPE 4)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS AND VITAMINS</medicinalproduct>
        <drugdosagetext>THE PATIENT WAS TAKING UNSPECIFIED GNC VITAMINS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518354-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-530071</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>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugdosagetext>REPORTED AS 'PILL'</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-530101</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>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518356-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>P099799</drugbatchnumb>
        <drugdosagetext>480MCG/0.8ML  QDAY PRN  SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518357-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>200 MG  BID  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL W/CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518358-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2007JP18703</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518359-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04263</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>25MG-300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1534</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>6X100MG/OVERDOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
        <drugtreatmentduration>76320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518360-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SPV1-2007-04120</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>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>405      (LANTHANUM CARBONATE)</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, ORAL; 2250 MG, ORAL;  750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>405      (LANTHANUM CARBONATE)</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, ORAL; 2250 MG, ORAL;  750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>405      (LANTHANUM CARBONATE)</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, ORAL; 2250 MG, ORAL;  750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>405      (LANTHANUM CARBONATE)</medicinalproduct>
        <drugauthorizationnumb>21468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, ORAL; 2250 MG, ORAL;  750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS                (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN  (DIGITOXIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAKUBAN (FLURBIPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL (BISACODYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA ALEXANDRINA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518361-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2005US03729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST RECONSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASTIC SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</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>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>.125 MG 1X DAY  PO  (DURATION: SEVERAL YEARS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518363-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SOLVAY-00307000446</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOGEL</medicinalproduct>
        <drugauthorizationnumb>21015</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S); OPEN LABEL PHASE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANDROGEN DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN BASAL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOGEL VS PLACEBO</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN; BLINDED PHASE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANDROGEN DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA-LIPONSAURE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSUMAN RAPID</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518364-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50MG  DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518365-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007US002746</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007JP004889</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-07P-127-0420508-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518368-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09419</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>75539</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXERUTINS                (TROXERUTIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOSEDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2007BH008956</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518370-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007IT09330</companynumb>
    <primarysource>
      <reportercountry>ITALY</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOSPORIN</medicinalproduct>
        <drugauthorizationnumb>65017</drugauthorizationnumb>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>375 MG/M2, QW, INFUSION</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS                (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTALBITAL ACETAMINOPHEN AND CAFFEINE</medicinalproduct>
        <drugbatchnumb>C0080807A</drugbatchnumb>
        <drugdosagetext>1+1/2 TABLET  TWICE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTALBITAL ACETAMINOPHEN AND CAFFEINE</medicinalproduct>
        <drugbatchnumb>C0080807A</drugbatchnumb>
        <drugdosagetext>1+1/2 TABLET  TWICE DAILY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00207034156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070330</drugenddate>
        <drugtreatmentduration>346</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRAPERITONEAL NUTRITION</medicinalproduct>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH008837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRAPERITONEAL NUTRITION</medicinalproduct>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUCOL/TISSEEL KIT STIM4</medicinalproduct>
        <drugbatchnumb>VNT3F125</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CRANIOTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518377-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>12 MG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007PL09340</companynumb>
    <primarysource>
      <reportercountry>POLAND</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>65017</drugauthorizationnumb>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-WYE-G00604107</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070728</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007GB09414</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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>300 MG  ONCE A DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-530563</companynumb>
    <primarysource>
      <reportercountry>GREECE</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>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>17581</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMESULID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-515381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>82824</drugbatchnumb>
        <drugdosagetext>360 MCG IN 1 ML SOLUTION ADMINISTERED SUBCUTANEOUS ONCE WEEKLY FOR 12 WEEKS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070730</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugbatchnumb>82824</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: VIAL. 180 MCG IN 1 ML SOLUTION ADMINISTERED SUBCUTANEOUS ONCE WEEKLY FOR 36 WEEKS.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>52211</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>GIVEN IN SPLIT DOSES IN THE MORNING AND IN THE EVENING FOR 48 WEEKS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>NEBULIZER.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-511387</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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-472986</companynumb>
    <primarysource>
      <reportercountry>CANADA</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugauthorizationnumb>019591</drugauthorizationnumb>
        <drugdosagetext>PATIENT TOOK ONLY ONE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>FORM: SR TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-460902</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>PATIENT REPORTED TO BE IN WEEK 19 OF TREATMENT.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 180MCG/0.5ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>PATIENT ON WEEK 19 OF TREATMENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>THE PATIENT TOOK ^A LITTLE PIECE^ EVERY DAY, THEN A ^WHOLE ASPIRIN^ ONCE DAILY SINCE EVENT OF TIA.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518388-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01762</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA00953</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>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0710USA06863</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugauthorizationnumb>012649</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASVERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071014</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULOBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRACHEAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071010</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518391-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0710USA06222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugauthorizationnumb>020864</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0706USA02219</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>011664</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA00548</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGSIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA00950</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>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLARY THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <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>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</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>FORTEO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518395-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA02838</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>GASTROENTERITIS VIRAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA02345</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugauthorizationnumb>20752</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0711USA02332</companynumb>
    <primarysource>
      <reportercountry>JAPAN</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 PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALPORT'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0707USA04743</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>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050826</drugenddate>
        <drugtreatmentduration>765</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0704USA05978</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>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ATOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHONDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0708USA00140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060523</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518401-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0711USA01700</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</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>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071002</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX (MORNIFLUMATE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518402-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0709USA00908</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019510</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070831</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN AND PYRIDOXINE HYDROCHLORIDE AND THIAMINE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070806</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070816</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518403-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0609USA00785</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>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS TRICHOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-525876</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>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04263</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>25MG-300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1534</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>6X100MG/OVERDOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071025</drugenddate>
        <drugtreatmentduration>156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
        <drugtreatmentduration>76320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518406-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>17762</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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugauthorizationnumb>75841</drugauthorizationnumb>
        <drugdosagetext>30 MG TOTAL IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG  ONCE/DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG  ONCE/DAY  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DK09464</companynumb>
    <primarysource>
      <reportercountry>DENMARK</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>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOL                  (CAPTOPRIL)</medicinalproduct>
        <drugauthorizationnumb>74363</drugauthorizationnumb>
        <drugdosagetext>150 MG/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518409-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2007BH008957</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-250022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>N04298, N04059</drugbatchnumb>
        <drugdosagetext>1000 MG, DAYS 1+15</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>7 MG, UNK</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09431</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugauthorizationnumb>73288</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GODAMED                      (ACETYLSALICYLIC ACID, AMINOACETIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518412-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>160 MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518413-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09383</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugauthorizationnumb>89959</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN V</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN+TAZOBACTAM (NGX)(PIPERACILLIN, TAZOBACTAM) UNKNOWN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID'S(NO INGREDIENTS/SUBTANCES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES (NO INGREDIENT/SUBSTANCES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOFETILIDE 0.125 MG, 0.25 MGPFIZER</medicinalproduct>
        <drugbatchnumb>6YR008F</drugbatchnumb>
        <drugdosagetext>0.125 MG, 0.25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOFETILIDE</medicinalproduct>
        <drugbatchnumb>6YR02</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN 20 MG AMERICAN HEALTH</medicinalproduct>
        <drugbatchnumb>073349</drugbatchnumb>
        <drugdosagetext>20 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007DE09172</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76877</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>CYCLICAL, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FALLOPIAN TUBE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugdosagetext>300 MG, CYCLICAL</drugdosagetext>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518416-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518417-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugbatchnumb>19</drugbatchnumb>
        <drugdosagetext>7.5 MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518418-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>HUMIRA EVERY 15 DAYS SQ MONTHS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518419-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANIC ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VISCOSITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugdosagetext>1 MG / 1 PILL 1X DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518420-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2007BH007862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUCOL/TISSEEL KIT STIM4</medicinalproduct>
        <drugbatchnumb>VNT3F131</drugbatchnumb>
        <drugdosagetext>DOSE UNIT:UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CRANIOTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518421-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2007-0014301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG AND 7.5MG 7.5MG FRI, 5MG AOD PO LONGTERM, OVER A YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>200MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2007JP09432</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOPNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>64150</drugauthorizationnumb>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>APPROXIMATELY ONE YEAR</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-12257</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>45 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2007SP022610</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>;SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518427-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-SYNTHELABO-F01200700507</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</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 NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400MG/M2 IV BOLUS AND 600MG/M2 CONTINUOUS INFUSION Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>DOSE NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070403</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-A03200706394</companynumb>
    <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>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518429-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-SYNTHELABO-F03200700031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B1</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>768 MG (400 MG/M2, 250 MG/M2)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021492</drugauthorizationnumb>
        <drugdosagetext>250 MG (130 MG/M2)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070124</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA00944</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOVERTEBRAL ANGLE TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC EMBOLISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20MG EVERY 4 WEEKS</drugdosagetext>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060322</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30MG EVERY 4 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-05P-087-0305305-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DESTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURILEMMOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARNERATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL (NON-PYRINE PREPARATION FOR COLD SYMPTOMS)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518432-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENENTECH-251100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101604</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM GEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518434-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20071101895</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20071004528</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYREX</medicinalproduct>
        <drugdosagetext>0.1 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T-ASS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE</medicinalproduct>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU200711000655</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518438-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS-MINERALS THERAPEUTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200711000981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US200709004638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.063</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRADUCTAL PAPILLOMA OF BREAST</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>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, DAILY (1/D)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP200710005469</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007084901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:1.5MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DAILY DOSE:100MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URISED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:60MG-FREQ:DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA D 24 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>TEXT:500/50-FREQ:DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518444-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PFIZER INC-2007077030</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518445-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>ONE PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518446-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094338</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>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS AND IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518447-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007081309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugbatchnumb>57P035A</drugbatchnumb>
        <drugauthorizationnumb>019684</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518448-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006113854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.5</patientweight>
      <patientsex>2</patientsex>
      <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-07P-167-0424012-00</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>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URGE INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.909</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BED REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006150147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518453-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006150901</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518454-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007093925</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518455-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2007052187</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOXAN LP</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOMA BENIGN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOXAN LP</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518456-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006153366</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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2006122308</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2007CG01545</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518459-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW25601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518460-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2007AP07108</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13297</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070924</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518461-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>715 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>343 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY OTC NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518462-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>78 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>3.51 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518463-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007051849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N0401059,B608</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
        <drugdosagetext>FREQ:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518464-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2007093476</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>009987</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:30MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EOSINOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518465-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007034316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>021341</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071115</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2007094573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>248 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>13.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VIII LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>.9 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518470-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>83.4619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB 150 MG</medicinalproduct>
        <drugdosagetext>150 MG DAILY 047</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB 15 MG/KG</medicinalproduct>
        <drugdosagetext>15 MG/KG EVERY 3 WEEKS 041</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB 15 MG/KG</medicinalproduct>
        <drugdosagetext>15 MG/KG EVERY 3 WEEKS 041</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518471-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</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>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>DS, 1 TABLET TWICE PER DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>5518472-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20080405</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20071113</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20071113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.151</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>1 TAB DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat